TWI640298B - Systems, devices, and methods for bodily fluid sample collection - Google Patents

Abstract

本發明係提供體液樣本採集系統、裝置及方法。所述裝置係可包括第一部分，其構成包括至少一樣本採集通道，該樣本採集通道被配置為籍由一第一類型動力將該液體樣本抽吸入該樣本採集通道中。該樣本採集裝置亦可包括一第二部分，其構成包括一樣本容器用於接收樣本採集通道中所採集之體液樣本，該樣本容器可***作地與該採集通道液體連通，由此當液體連通實現之時，所述容器即提供與第一動力不同之第二動力，將多數體液樣本從該通道移至容器中。 The invention provides a system, device and method for collecting body fluid samples. The device may include a first part, which is configured to include at least a sample collection channel configured to draw the liquid sample into the sample collection channel by a first type of power. The sample collection device may also include a second part, which is configured to include a sample container for receiving the body fluid sample collected in the sample collection channel, the sample container may be operatively in fluid communication with the collection channel, whereby when the liquid is in communication When implemented, the container provides a second power different from the first power to move most of the body fluid sample from the channel to the container.

Description

用於體液採樣之系統、裝置及方法 System, device and method for sampling body fluid

本發明係有關於用於體液採樣之系統、裝置及方法。 The invention relates to a system, device and method for sampling body fluids.

發明背景 Background of the invention

實驗室測試中所用血樣經常籍由將皮下注射針頭刺入對象靜脈中的靜脈穿刺採得。皮下注射針頭所抽出的血液可被直接吸入注射器或者一個或多個密封小瓶中，以供後繼處理使用。當靜脈穿刺難以或無法實施，諸如對於新生兒等情形，可採用足跟穿刺或其它部位穿刺等非靜脈穿刺採集血樣供測試。所採集之血樣通常經封裝、傳遞至處理中心以供分析。 Blood samples used in laboratory tests are often collected by venipuncture that pierces a hypodermic needle into a subject's vein. The blood drawn by the hypodermic needle can be directly drawn into the syringe or one or more sealed vials for subsequent treatment. When venipuncture is difficult or impossible to perform, such as for newborns, non-venous puncture such as heel puncture or other site puncture can be used to collect blood samples for testing. The collected blood samples are usually packaged and transferred to the processing center for analysis.

然而，習用體液樣本採集及測試技術具有缺陷。舉例而言，最基礎之測試除外，當前可用之血液測試通常須要求從對象抽取相當大量之血液。因須要大量之血液，經常不採用從痛苦較少和/或侵入較少之替用部位抽取血樣，蓋因其無法產出習用測試方式所需的血液量。在某些情形下，因靜脈穿刺引起之病人顧慮可使病人不遵守測試方案。此外，習用採集技術試圖將單一血樣分配入不 同容器供不同的分析前處理，由此引入不必要之複雜性。 However, conventional body fluid sample collection and testing techniques have drawbacks. For example, except for the most basic tests, currently available blood tests usually require a considerable amount of blood to be drawn from the subject. Because a large amount of blood is required, blood samples are often not taken from alternative sites with less pain and / or less invasion, because Gai cannot produce the amount of blood required for conventional testing methods. In some cases, patient concerns due to venipuncture may cause patients to fail to follow the test protocol. In addition, conventional collection techniques try to distribute a single blood sample into The same container is provided for different pre-analysis treatments, thereby introducing unnecessary complexity.

發明內容 Summary of the invention

本揭示所述至少一些或全部實施例克服了與習用技術相關的至少一些缺點。儘管本文所述實施例通常於獲取血樣之文中描述，應暸解的乃是本文所述實施例並非限於血液樣本，還可適用於獲取其他液體或體樣以供分析。 The at least some or all embodiments described in this disclosure overcome at least some of the disadvantages associated with conventional techniques. Although the embodiments described herein are generally described in the text of obtaining blood samples, it should be understood that the embodiments described herein are not limited to blood samples, but can also be applied to obtain other liquids or body samples for analysis.

於本文所述實施例中，係提供有一種用於採集體液樣本之裝置。此實施例可被用於精確地採集經常與非靜脈血液抽取相關之小體積體液樣本。於一個非限制性實例中，該樣本體積為約1mL或更少。可選地，該樣本體積為約900uL或更少。可選地，該樣本體積為約800uL或更少。可選地，該樣本體積為約700uL或更少。可選地，該樣本體積為約600uL或更少。可選地，該樣本體積為約500uL或更少。可選地，該樣本體積為約400uL或更少。可選地，該樣本體積為約300uL或更少。可選地，該樣本體積為約200uL或更少。可選地，該樣本體積為約100uL或更少。可選地，該樣本體積為約90uL或更少。可選地，該樣本體積為約80uL或更少。可選地，該樣本體積為約70uL或更少。可選地，該樣本體積為約60uL或更少。可選地，該樣本體積為約50uL或更少。 In the embodiments described herein, a device for collecting body fluid samples is provided. This embodiment can be used to accurately collect small volumes of body fluid samples often associated with non-venous blood draws. In one non-limiting example, the sample volume is about 1 mL or less. Optionally, the sample volume is about 900 uL or less. Optionally, the sample volume is about 800 uL or less. Optionally, the sample volume is about 700 uL or less. Optionally, the sample volume is about 600 uL or less. Optionally, the sample volume is about 500 uL or less. Optionally, the sample volume is about 400 uL or less. Optionally, the sample volume is about 300 uL or less. Optionally, the sample volume is about 200 uL or less. Optionally, the sample volume is about 100 uL or less. Optionally, the sample volume is about 90 uL or less. Optionally, the sample volume is about 80 uL or less. Optionally, the sample volume is about 70 uL or less. Optionally, the sample volume is about 60 uL or less. Optionally, the sample volume is about 50 uL or less.

於一個非限制性實例中，此裝置可被用於將該體液樣本直接分為並被置於各自容器中之兩份或更多不同 份。於一個非限制性實例中，此裝置係具有含有至少兩條樣本採集通道之第一部分，此第一部分配置為籍由一第一類型動力將該液體樣本抽吸入該等樣本採集通道中，其中，該等樣本採集通道之一具有設計用於與液體樣本混合之內部塗層，而另一樣本採集通道具有與前述內部塗層化學成分不同之另一內部塗層。該樣本採集裝置包括第二個部分，其組成乃數個樣本容器用於接收於樣本採集通道中所採集之體液樣本，該等樣本容器係可***作地與該等採集通道液體連通，由此當液體連通實現之時，所述容器即提供與第一動力不同之第二動力，以將多數體液樣本從該通道移至容器中。該等容器可以防止容器中液體樣本混合之方式放置。因此裝置可用於非靜脈抽取，其可能需要較長之時間獲取所需體積之樣本，於是立即使之與可塗於通道中之抗凝固劑之類的材料作用可防止通道於採集過程中過早堵塞。 In a non-limiting example, the device can be used to directly divide the body fluid sample and place it in two or more different parts of the respective container Copies. In a non-limiting example, the device has a first part containing at least two sample collection channels, the first part is configured to draw the liquid sample into the sample collection channels by a first type of power, wherein One of the sample collection channels has an internal coating designed to mix with the liquid sample, and the other sample collection channel has another internal coating with a chemical composition different from the aforementioned internal coating. The sample collection device includes a second part consisting of a plurality of sample containers for receiving body fluid samples collected in the sample collection channel, the sample containers are operably in fluid communication with the collection channels, thereby When liquid communication is achieved, the container provides a second power different from the first power to move the majority of body fluid samples from the channel to the container. These containers can be placed in a way that prevents the liquid samples in the container from mixing. Therefore, the device can be used for non-venous extraction, which may take a long time to obtain the required volume of sample, so it is immediately used with materials such as anticoagulants that can be applied to the channel to prevent the channel from being premature during the collection process Clogged.

於本文所述之另一實施例中，係提供有一種用於採集體液樣本之裝置。此裝置包括數條樣本採集通道之第一部分，其中，至少兩條樣本採集通道配置為籍由一第一類型動力同時將該液體樣本抽吸入該至少兩條樣本採集通道的每一條中。該裝置亦可包括第二部分，其組成乃數個樣本容器用於接收於樣本採集通道中所採集之體液樣本，其中，該樣本容器具有不與該等採集通道液體連通之第一狀態，及該樣本容器可***作地與該等採集通道液體連通之第二狀態，由此當液體連通實現之時，所述容器即 提供與第一動力不同之第二動力，以將體液樣本從該通道移至容器中。 In another embodiment described herein, a device for collecting body fluid samples is provided. The device includes a first part of several sample collection channels, wherein at least two sample collection channels are configured to simultaneously draw the liquid sample into each of the at least two sample collection channels by a first type of power. The device may also include a second part consisting of several sample containers for receiving body fluid samples collected in the sample collection channel, wherein the sample container has a first state that is not in fluid communication with the collection channels, and The sample container can be operatively in liquid communication with the collection channels in a second state, whereby when liquid communication is achieved, the container is A second power different from the first power is provided to move the body fluid sample from the channel to the container.

於本文所述之又一實施例中，係提供有一種方法，其包括使用一種具有至少兩條樣本採集通道之樣本採集裝置將最小量之樣本計量入至少兩條通道中，該至少兩條樣本採集通道配置為籍由一第一類型動力同時將該液體樣本抽吸入該至少兩條樣本採集通道的每一條中。當所需之量之樣本液體已被確認處於樣本採集通道中後，該等樣本採集通道與樣本容器之間實現液體連通，由此所述容器即提供與用於採集樣本的第一動力不同之第二動力，從而將體液樣本從該通道移至容器中。於一些替換實施例中，並未排除僅使用單條通道採集體液之裝置或具有數個通道卻未同時採集之裝置。可選地，樣本液體之採集可於不使用吸收性材料下完成。 In yet another embodiment described herein, a method is provided that includes using a sample collection device having at least two sample collection channels to measure a minimum amount of samples into at least two channels, the at least two samples The collection channel is configured to simultaneously draw the liquid sample into each of the at least two sample collection channels by a first type of power. When the required amount of sample liquid has been confirmed to be in the sample collection channel, liquid communication is achieved between the sample collection channel and the sample container, whereby the container provides a different power from the first power used to collect the sample The second power, thereby moving the body fluid sample from the channel to the container. In some alternative embodiments, devices that only use a single channel to collect body fluids or devices that have multiple channels but are not collected at the same time are not excluded. Alternatively, the sample liquid can be collected without the use of absorbent materials.

於一個實施例中，樣本採集與將樣本引入樣本前處理裝置之間具有一時間間隔。於一個非限制性實例中，該過程為一非連續過程。樣本採集發生於一處理站，隨後該樣本被移至第二處理站。此第二處理站可能位於樣本建築物中。可選地，此第二處理站可能位於另一地點，樣本需經步行、駕駛、飛行、轉運帶運送、置於傳送裝置中，或置於傳送容器中方可抵達此第二處理站。以此方式，過程中之間斷容許了樣本運送需要之時間。 In one embodiment, there is a time interval between sample collection and introduction of the sample into the sample pre-processing device. In a non-limiting example, the process is a discontinuous process. The sample collection takes place at a processing station, after which the sample is moved to a second processing station. This second processing station may be located in the sample building. Alternatively, the second processing station may be located at another location, and the sample needs to be transported by walking, driving, flying, transfer belt, placed in a transfer device, or placed in a transfer container to reach the second processing station. In this way, the intermittent process allows for the time required for sample transport.

於本文所述之另一實施例中，還可使樣本容器具有分隔凝膠，由此此凝膠可將樣本全血之不含細胞部分 與細胞部分或其它固體或半固體部分分開。此類凝膠或其它相似分隔材料可於樣本被引入樣本容器前、過程中或之後加入樣本容器。此分隔材料之密度可處於細胞與溶液成分之密度之間，如此該材料即可於離心等分離過程中，籍由流至溶液及非溶液樣本層之間一位置分離樣本成分。於離心分離後，此分隔材料停止流動，並作為軟性隔離保持在各層之間。於一些實施例中，此分隔材料還可經進一步處理硬化成更具剛性之隔離。於一個非限制性實例中，此分隔材料可為紫外線固化材料，諸如但不限於以山梨醇為基礎之凝膠因子於二丙烯酸酯寡聚物中的觸變凝膠。可將整個樣本容器或可選地，將具有該紫外線固化材料之部分暴露於紫外線下一段時間，例如但不限於10至30秒，以硬化該材料。此硬化可包括交聯紫外線固化材料中的材料。可選地，此紫外線固化材料可與習用分隔凝膠材料一起使用，使得僅有一側(溶液側或固體側)與紫外線固化材料接觸。可選地，此紫外線固化材料可與第三材料一起使用，使得此紫外線固化材料位於兩種分隔材料之間，且不與樣本之溶液及非溶液部分直接接觸。 In another embodiment described herein, the sample container can also be provided with a separating gel, whereby this gel can remove the cell-free portion of the whole blood of the sample Separated from cell parts or other solid or semi-solid parts. Such gels or other similar separation materials can be added to the sample container before, during, or after the sample is introduced into the sample container. The density of the separation material can be between the density of the cells and the solution components, so that the material can be separated into a position between the solution and the non-solution sample layer by centrifugation and the like during the separation process. After centrifugal separation, this separation material stops flowing and remains between the layers as a soft barrier. In some embodiments, the separation material can be further cured to become a more rigid insulation. In a non-limiting example, the separation material may be an ultraviolet curing material, such as but not limited to a thixotropic gel based on a sorbitol-based gel factor in a diacrylate oligomer. The entire sample container or, optionally, the portion with the ultraviolet curing material may be exposed to ultraviolet light for a period of time, such as but not limited to 10 to 30 seconds, to harden the material. This hardening may include cross-linking the materials in the ultraviolet curing material. Alternatively, this ultraviolet curing material can be used with conventional separation gel materials so that only one side (solution side or solid side) is in contact with the ultraviolet curing material. Optionally, the ultraviolet curing material can be used together with the third material so that the ultraviolet curing material is located between the two separation materials and does not directly contact the solution and non-solution portions of the sample.

於本文所述至少一個實施例中，係提供有以液體形態將小體積體液從某一地點物理運送至另一地點的多種方法。作為非限制性實例，於某一採集地以液體形態採集樣本，將其以液體形態運送，並以液體形態抵達某一分析地。於許多實施例中，此液體形態於運送過程中並非被置於多孔基質、吸收性材料、網狀或相似材料中，此類材 料會妨礙於目的地以液體形態提取樣本。於一個實施例中，各樣本器皿中之樣本的小體積位於約1ml至約500μl之範圍中。可選地，小體積位於約500μl至約250μl之範圍中。可選地，小體積位於約250μl至約100μl之範圍中。可選地，小體積位於約100μl至約50μl之範圍中。可選地，小體積位於約80μl至約40μl之範圍中。可選地，小體積位於約40μl至約1μl之範圍中。可選地，小體積位於約1μl至約0.3μl之範圍中。可選地，小體積位於約0.3μl或更少之範圍中。 In at least one embodiment described herein, there are multiple methods for physically transporting small volumes of body fluids from one location to another in a liquid form. As a non-limiting example, a sample is collected in a liquid form at a certain collection place, transported in a liquid form, and arrives at a certain analysis place in a liquid form. In many embodiments, this liquid form is not placed in a porous matrix, absorbent material, mesh or similar material during transportation. It may prevent the destination from taking samples in liquid form. In one embodiment, the small volume of the sample in each sample vessel is in the range of about 1 ml to about 500 μl. Optionally, the small volume is in the range of about 500 μl to about 250 μl. Optionally, the small volume is in the range of about 250 μl to about 100 μl. Optionally, the small volume is in the range of about 100 μl to about 50 μl. Optionally, the small volume is in the range of about 80 μl to about 40 μl. Optionally, the small volume is in the range of about 40 μl to about 1 μl. Optionally, the small volume is in the range of about 1 μl to about 0.3 μl. Alternatively, the small volume is in the range of about 0.3 μl or less.

於本文所述另一實施例中，此運送容器中每單位面積可具有高密度樣本器皿，其於運送過程中固定，惟於目的地可被移除。於一個非限制性實例中，此樣本器皿放置為一個陣列，其中當從上往下觀察該陣列時，每平方英寸具有至少六個樣本器皿。可選地，當從上往下觀察該陣列時，每平方英寸具有至少八個樣本器皿。可選地，當從上往下觀察該陣列時，每平方英寸具有至少十個樣本器皿。任何傳統技術上運輸多個樣本通常是使樣本器皿以鬆散、不加約束之形式放置於大袋子中。於一些實施例中，此運送容器可容置諸如採自同一對象之特定樣本器皿，使其與相鄰樣本器皿相比具有較近的水平或其它間隔，從而可目視識別其採自同一對象。可選地，此運送容器可具有開口以容納將一個或多個樣本器皿放置一起之載體，其中所述器皿具有諸如但不限於採自同一對象之相同特性。 In another embodiment described herein, the shipping container may have a high-density sample vessel per unit area, which is fixed during shipping but can be removed at the destination. In a non-limiting example, the sample vessels are placed as an array, where when the array is viewed from above, there are at least six sample vessels per square inch. Optionally, when viewing the array from top to bottom, there are at least eight sample vessels per square inch. Optionally, when viewing the array from top to bottom, there are at least ten sample vessels per square inch. Any traditional technique for transporting multiple samples is usually to place the sample vessels in large bags in a loose, unconstrained form. In some embodiments, the shipping container may house a specific sample vessel, such as taken from the same object, so that it has a closer level or other interval than adjacent sample vessels, so that it can be visually identified that it was taken from the same object. Alternatively, this shipping container may have an opening to accommodate a carrier that holds one or more sample vessels together, where the vessels have the same characteristics such as but not limited to being taken from the same object.

於實施例中，所述樣本器皿適用於幫助樣本保 持液體形態。於實施例中，於所述樣本抵達樣本器皿前，以適合保持樣本之液體形態的方式處理所述樣本。舉例而言，樣本器皿可包括一種抗凝劑，或可於樣本運輸至或進入樣本器皿前或過程中，使用一種抗凝劑處理該樣本。於實施例中，抗凝劑可選自肝磷脂(如肝素鋰或肝素鈉)、EDTA、四羥基香豆素、維生素K拮抗劑(VKA)抗凝劑、某種抗凝劑或其它添加劑。除單位面積高密度之外，於有些實施例中此運送容器也包含很多種類樣本，包括容納採自複數個不同對象之樣本的運送容器實施例。作為非限制性實例，此運送容器可容置採自某一對象之四件樣本、採自另一對象之兩件樣本等等直至運送容器中大多數或全部可用空位被填滿。 In the embodiment, the sample vessel is suitable for helping sample preservation Hold liquid form. In an embodiment, before the sample reaches the sample vessel, the sample is processed in a manner suitable for maintaining the liquid form of the sample. For example, the sample vessel may include an anticoagulant, or the sample may be treated with an anticoagulant before or during transport to or into the sample vessel. In an embodiment, the anticoagulant may be selected from heparin (such as lithium heparin or sodium heparin), EDTA, tetrahydroxycoumarin, vitamin K antagonist (VKA) anticoagulant, some anticoagulant, or other additives. In addition to the high density per unit area, in some embodiments, the shipping container also contains many types of samples, including a shipping container embodiment that contains samples taken from a plurality of different objects. As a non-limiting example, the shipping container may hold four samples taken from one object, two samples taken from another object, etc. until most or all available spaces in the shipping container are filled.

應暸解，各樣本係可被最終用於個別選擇的分析，且至少於一個實施例中，未根據將進行之測試而於運送容器中分組。作為非限制性實例，運送容器中的樣本不是全部採集用於同樣的測試。習用測試系統或許只能將最終將用於完全相同測試的樣本成組運送。於本文所述至少一個實施例中，具有多種不同樣本，各樣本均被指定接收其自己的一套測試。在此類實施例中，運送容器中的分組不僅限於指定用於同樣測試之樣本。這可進一步簡化樣本處理，蓋因不需按將進行之測試進一步分離樣本運送。此運送容器之有些實施例包含採自至少三位或更多不同病患之樣本。此運送容器之有些實施例包含採自至少五位或更多不同病患之樣本。此運送容器之有些實施例包含採自至 少十位或更多不同病患之樣本。此運送容器之有些實施例包含採自至少二十位或更多不同病患之樣本。 It should be appreciated that each sample may be ultimately used for individually selected analysis, and in at least one embodiment, the samples are not grouped in shipping containers based on the tests to be performed. As a non-limiting example, not all samples in the shipping container are collected for the same test. Conventional testing systems may only be able to ship samples that will eventually be used for identical tests in groups. In at least one embodiment described herein, there are multiple different samples, each of which is designated to receive its own set of tests. In such embodiments, the grouping in the shipping container is not limited to samples designated for the same test. This further simplifies sample processing, as the cover does not need to be further separated and transported according to the test to be performed. Some embodiments of the shipping container include samples from at least three or more different patients. Some embodiments of the shipping container include samples from at least five or more different patients. Some embodiments of this shipping container include Ten or fewer samples from different patients. Some embodiments of the shipping container include samples from at least twenty or more different patients.

作為非限制性實例，本文所述一個實施例係可選地使用具有樣本器皿容置槽和/或樣本器皿支架之托盤。於一個實施例中，該托盤還可於因等待更多樣本或運送而儲存於冷室期間同時用作容置裝置。於一個實施例中，該托盤本身還可清潔及消毒，蓋因於一些實施例中，該托盤可從所述運送容器中移除。於一些實施例中，容器中之托盤可以平行於容器蓋之方式固定。可選地，該托盤可以與容器蓋形成某一角度之方式保持於容器中。可選地，該托盤可以不可移除之方式固定於容器之上。可選地，該托盤可與容器本身一體形成。可選地，相同或不同尺寸或架構之多個托盤可置於容器中。 As a non-limiting example, one embodiment described herein optionally uses a tray with a sample container receiving tank and / or a sample container holder. In one embodiment, the tray can also be used as a storage device during storage in the cold room due to waiting for more samples or transportation. In one embodiment, the tray itself can also be cleaned and sterilized, and in some embodiments, the tray can be removed from the shipping container. In some embodiments, the tray in the container may be fixed parallel to the container lid. Alternatively, the tray may be held in the container at an angle with the container lid. Optionally, the tray can be fixed on the container in a non-removable manner. Alternatively, the tray may be formed integrally with the container itself. Alternatively, multiple trays of the same or different sizes or configurations can be placed in the container.

於本文所述又一實施例中，係提供有運用具有提供主動和/或被動冷卻之整合熱控制單元和/或材料之運送容器運送小體積樣本器皿之方法。於一個實施例中，該熱控制材料可為但不限於嵌入式相變材料(PCM)，其將溫度維持於先前或所需溫度。作為非限制性實例，此相變材料可於材料會產生相變之臨界溫度附近抵制溫度變化。如嵌入有此PCM，則容器及被動冷卻元件可為合二為一。可選地，此運送容器可採用主動冷卻系統。可選地，此運送容器可採用主動冷卻系統維持和/或延長與被動冷卻部件相關之冷卻時間。 In yet another embodiment described herein, there is provided a method of transporting a small volume sample vessel using a transport container having an integrated thermal control unit and / or material that provides active and / or passive cooling. In one embodiment, the thermal control material may be, but not limited to, embedded phase change material (PCM), which maintains the temperature at a previous or desired temperature. As a non-limiting example, this phase change material can resist temperature changes around the critical temperature at which the material will undergo a phase change. If the PCM is embedded, the container and the passive cooling element can be combined into one. Alternatively, this shipping container may employ an active cooling system. Alternatively, the shipping container may employ an active cooling system to maintain and / or extend the cooling time associated with passive cooling components.

可選地，此方法包括將採自不同對象之多個樣 本器皿從某一溫度控制儲存區域轉移入運送容器中之單一步驟。作為非限制性實例，此單一步驟可將二十四或更多個樣本器皿一次性從儲存地點轉移入運送容器中某一固定位置。可選地，此單一步驟可將三十六或更多個樣本器皿一次性從儲存地點轉移入運送容器中某一固定位置。可選地，此單一步驟可將四十八或更多個樣本器皿一次性從儲存地點轉移入運送容器中某一固定位置。於此類實施例中，托盤最初可位於諸如但不限於冷藏庫之熱控制環境中，其中依次採集採自不同對象之樣本，直至達到所需數目為止。於一個此類實施例中，於運送容器中容置樣本器皿之托盤為於儲存區域容置樣本器皿之同一托盤。可選地，此托盤可為用於在裝載入運送容器內之前容置樣本之同樣儲存支架。蓋因將於運送容器中使用容置樣本器皿之相同托盤，此轉移過程中樣本遺失、遺忘於非熱控制環境等之風險被降低。因相當大程度地托盤中樣本器皿皆於熱控制環境中積累，且隨後以單一步驟轉移，所有樣本於從熱控制儲存區域轉移入運送容器之過程均經歷相當程度地相同之熱暴露。惟樣本器皿經歷相當程度地相同之暴露，因暴露時間不同而導致之各樣本間變異性較低。 Optionally, this method includes multiple samples taken from different objects The single step of transferring the vessel from a temperature-controlled storage area into a shipping container. As a non-limiting example, this single step can transfer twenty-four or more sample vessels from the storage location to a fixed location in the shipping container at once. Optionally, this single step can transfer thirty-six or more sample vessels from the storage location to a fixed location in the shipping container at once. Optionally, this single step can transfer forty-eight or more sample vessels from the storage location to a fixed location in the shipping container at once. In such embodiments, the tray may initially be located in a thermally controlled environment such as, but not limited to, a refrigerator, where samples taken from different subjects are sequentially collected until the desired number is reached. In one such embodiment, the tray that houses the sample vessels in the shipping container is the same tray that houses the sample vessels in the storage area. Alternatively, the tray may be the same storage rack used to hold the sample before loading into the shipping container. Because the lid will use the same tray that holds the sample container in the shipping container, the risk of sample loss and forgetting in a non-heat controlled environment during the transfer process is reduced. Since the sample containers in the tray are accumulated to a considerable extent in a thermally controlled environment and then transferred in a single step, all samples undergo considerable thermal exposure during the transfer from the thermally controlled storage area to the shipping container. However, the sample vessels experienced the same exposure to a certain extent, and the variability between samples due to the different exposure time was low.

可選地，此方法包括使用可個別定址之樣本器皿之架構。可選地，諸如位於同一載體中之多組樣本器皿可按預先分定之組別定址。可選地，甚至位於同一載體中之樣本器皿可個別定址。儘管其不為本文所述所有實施例之必要條件，此方法對從托盤載入和/或卸除樣本、樣本 器皿和/或樣本支架極有用處。 Optionally, this method includes the use of an individually addressable sample vessel architecture. Alternatively, multiple sets of sample vessels, such as in the same carrier, can be addressed in pre-assigned groups. Alternatively, even sample vessels located in the same carrier can be individually addressed. Although it is not a necessary condition for all the embodiments described herein, this method is suitable for loading and / or unloading samples Utensils and / or sample holders are extremely useful.

一些實施例可於運送容器之外另行使用又一容器，以提供更多物理保護和/或熱控制能力。一個或多個運送容器可置於此外盒中，隨後將此組合從某一地點運送至目標地。作為非限制性實例，可採用瓦楞塑料外盒形式，該外盒係構造成至少部分地包裹或封閉運送容器。於實施例中，外盒為其中所封閉之運送容器提供熱絕緣。一些實施例可採用具閉孔結構之擠塑式聚苯乙烯泡沫外盒。此外盒的一些實施例可採用熱塑成型板製成。此外盒的一些實施例可具有其自身之主動和/或被動熱控制單元。於實施例中，外盒為其中所封閉之一個或多個運送容器提供提供冷卻及熱絕緣。此外盒的一個或多個實施例可配置為容納一個或多個運送容器。可選地，此容器還可籍由為運送容器提供處於所需溫度範圍內之熱控環境，從而為該運送容器提供額外熱控制。可選地，此溫度範圍為約1至10C，可選地為2至8C，或2至6C。 Some embodiments may use another container in addition to the shipping container to provide more physical protection and / or thermal control capabilities. One or more shipping containers can be placed in the outer box, and then the combination is transported from a certain location to a destination. As a non-limiting example, a corrugated plastic outer box may be used that is configured to at least partially wrap or close the shipping container. In an embodiment, the outer box provides thermal insulation for the transport container enclosed therein. Some embodiments may use an extruded polystyrene foam outer box with a closed cell structure. In addition, some embodiments of the box may be made of a thermoformed plate. In addition, some embodiments of the cartridge may have its own active and / or passive thermal control unit. In an embodiment, the outer box provides cooling and thermal insulation for one or more shipping containers enclosed therein. In addition, one or more embodiments of the cassette may be configured to accommodate one or more shipping containers. Optionally, the container can also provide a thermal control environment within the desired temperature range for the shipping container, thereby providing additional thermal control for the shipping container. Optionally, this temperature range is about 1 to 10C, optionally 2 to 8C, or 2 to 6C.

於本文所述又一實施例中，係提供於若干冷卻循環後對運送容器進行熱傳特徵化之方法。作為非限制性實例，經特定次數之循環後，運送容器可被熱傳特徵化，以確保此容器繼續運作於理想值內。 In yet another embodiment described herein, a method for heat transfer characterization of a shipping container after several cooling cycles is provided. As a non-limiting example, after a certain number of cycles, the shipping container can be characterized by heat transfer to ensure that the container continues to operate within the desired value.

此容器和或托盤之一些實施例可包括熱變化指示器。於一個非限制性實例中，此指示器被整合於運送容器、托盤和/或外盒之可見表面。於一個非限制性實例中，熱色變墨水可用作熱變化指示器，尤其於此熱變化導 致溫度超出所需範圍之情形中。於一個實施例中，此指示器可被配置為使整盒和/或托盤改變顏色。此變化可為可逆或不可逆。可選地，此指示器僅定位於運送容器和/或托盤之所選部分，而不是整個容器或托盤。 Some embodiments of this container and or tray may include a thermal change indicator. In one non-limiting example, this indicator is integrated on the visible surface of the shipping container, tray, and / or outer box. In a non-limiting example, the thermal color change ink can be used as a thermal change indicator, especially for the thermal change guide In case the temperature exceeds the required range. In one embodiment, this indicator may be configured to change the color of the entire box and / or tray. This change can be reversible or irreversible. Optionally, this indicator is only positioned on the selected part of the shipping container and / or pallet, not the entire container or pallet.

於本文所述一個實施例中，係提供有包括於對象表面採集體液樣本之方法，其中所採集樣本被保存於一個或多個樣本器皿中；提供運送容器以第一方位容納至少兩個或多個樣本器皿；並安排使樣本器皿於運送容器中從第一位置運送至第二位置，其中各樣本器皿抵達第二位置時，其大多數體液樣本為非吸收、未添加基質形式，可以液體形態從樣本器皿中移除，且其中各樣本器皿中樣本量不超過約2ml。 In one embodiment described herein, there is provided a method including collecting a body fluid sample on a surface of a subject, wherein the collected sample is stored in one or more sample vessels; a shipping container is provided to accommodate at least two or more in a first orientation Sample vessels; and arrange for the sample vessels to be transported from the first position to the second position in the transport container, wherein when each sample vessel reaches the second position, most of its body fluid samples are in the form of non-absorbed, no added matrix, and can be in liquid form Remove from the sample vessel, and the sample volume in each sample vessel does not exceed about 2 ml.

於本文所述另一實施例中，係提供用於運送複數個樣本器皿之方法，該方法包括：提供配置為可容納至少五個或更多樣本器皿之容器，各樣本器皿內裝有毛細管血；並安排使樣本器皿於容器中從第一位置運送至第二位置，其中各樣本器皿抵達時，其大多數毛細管血為非吸收液體形態，可從樣本器皿中移除用於進一步處理，且其中各樣本器皿中毛細管血量不超過約2ml。 In another embodiment described herein, a method for transporting a plurality of sample vessels is provided. The method includes: providing a container configured to hold at least five or more sample vessels, each sample vessel containing capillary blood ; And arrange for the sample vessels to be transported from the first position to the second position in the container, wherein when each sample vessel arrives, most of its capillary blood is in the form of non-absorbed liquid, which can be removed from the sample vessel for further processing, and The blood volume of capillary in each sample vessel does not exceed about 2ml.

於本文所述另一實施例中，係提供用於運送包含生物樣本之複數個樣本器皿之方法，該方法包括：提供配置為可容納至少五個或更多樣本器皿之容器，其中各樣本器皿中樣本量不超過約2ml；並將容器及樣本器皿從第一位置運送至第二位置，其中各樣本器皿抵達時，其大多 數樣本為非吸收液體形態，可從樣本器皿中移除用於進一步處理。 In another embodiment described herein, a method for transporting a plurality of sample vessels containing biological samples is provided, the method comprising: providing a container configured to accommodate at least five or more sample vessels, wherein each sample vessel The medium sample volume does not exceed about 2ml; and the container and sample vessel are transported from the first position to the second position, where most of the sample vessels arrive Several samples are in non-absorbent liquid form and can be removed from the sample vessel for further processing.

於本文所述另一實施例中，係提供用於運送包含毛細管血之複數個樣本器皿之方法，該方法包括：提供配置為可容納至少五個或更多樣本器皿且具有熱控制內部區域之容器，該受控配置為該容器至少一個冷卻表面朝向樣本器皿，並依據使該內部區域於運送過程中維持於約1至10C且不凍結血樣之溫度特徵，傳送受控之熱冷卻釋放；且將容器從第一位置運送至第二位置，其中各樣本器皿抵達時，其大多數毛細管血為非吸收液體形態，可從樣本器皿中移除用於進一步處理。 In another embodiment described herein, a method for transporting a plurality of sample vessels containing capillary blood is provided, the method comprising: providing a heat control internal area configured to accommodate at least five or more sample vessels A container, the controlled configuration is such that at least one cooling surface of the container faces the sample vessel, and depending on the temperature characteristics of maintaining the internal area at about 1 to 10C during transportation without freezing the blood sample, delivering controlled thermal cooling release; and The container is transported from the first location to the second location, where most of the capillary blood of each sample vessel arrives in a non-absorbable liquid form and can be removed from the sample vessel for further processing.

於本文所述另一實施例中，係提供用於運送複數個血樣器皿之方法，該方法包括：運送具有熱控制內部區域之容器，該容器配置為可以陣列架構容納至少10個或更多樣本器皿，其中各器皿以自由流動、非吸收形態容納其大多數血樣，且其中各器皿中有約1ml或更少之血液，各器皿具有至少為部分真空氣氛之內部，其中樣本器皿以陣列架構放置，使所述樣本器皿相對於冷卻表面以受控間距及方位定位，其中具有至少一條從該表面至樣本器皿之優先熱路徑。 In another embodiment described herein, a method for transporting a plurality of blood sample vessels is provided. The method includes: transporting a container having a thermally controlled internal area, the container configured to accommodate at least 10 or more samples in an array architecture Vessels, where each vessel contains most of its blood sample in a free-flowing, non-absorbable form, and where each vessel has about 1 ml or less of blood, each vessel has an interior that is at least partially vacuum atmosphere, where the sample vessels are placed in an array , The sample vessel is positioned at a controlled distance and orientation relative to the cooling surface, with at least one preferential thermal path from the surface to the sample vessel.

於本文所述另一實施例中，係提供用於運送複數個小於1ml樣本器皿之方法，該方法包括：樣本轉移入各樣本器皿前，將樣本與抗凝劑混合；各樣本器皿與某一對象及一套所要求之樣本測試相關聯；且運送以陣列架構 容納該複數個小於1ml樣本器皿之熱控制容器，其中各器皿以自由流動、非吸收形態容納其大多數樣本，其中器皿放置形式為，各容器中至少兩個器皿與各對象相關聯，其中至少第一樣本於基質中包括第一抗凝劑，第二樣本於基質中包括第二抗凝劑。 In another embodiment described herein, a method for transporting a plurality of sample vessels of less than 1 ml is provided. The method includes: before transferring the sample into each sample vessel, mixing the sample with the anticoagulant; each sample vessel is combined with a certain The object is related to a set of required sample tests; and shipped in an array structure A thermal control container containing the plurality of sample vessels of less than 1 ml, wherein each vessel contains most of its samples in a free-flowing, non-absorption form, wherein the vessel is placed in the form that at least two vessels in each vessel are associated with each object, at least The first sample includes a first anticoagulant in the matrix, and the second sample includes a second anticoagulant in the matrix.

於本文所述另一實施例中，係提供有一種方法，該方法包括：a)將所述複數個樣本器皿置於一個溫度控制樣本器皿中，該樣本器皿具有一種受控統一熱特徵及高融解熱材料，其配置為與樣本器皿熱連通，其中該材料不導致樣本器皿中樣本液體之凍結；b)將所述熱曲線樣本器皿置於由運送容器之至少頂壁和底壁限定而成之產品腔中；c)使一個主動冷卻裝置與所述腔熱連通，由此該冷卻裝置於啟動之時適合於冷卻所述腔，該吸收冷卻裝置包括一個吸收器，其位置便於驅散此吸收器中產生之熱量至所述產品腔外；d)啟動所述冷卻裝置以開始冷卻該腔；e)將該運送容器從第一位置運送至第二位置；及f)從該腔中移走該產品。 In another embodiment described herein, a method is provided that includes: a) placing the plurality of sample vessels in a temperature-controlled sample vessel, the sample vessel having a controlled uniform thermal characteristic and high Melting thermal material, which is configured to be in thermal communication with the sample vessel, wherein the material does not cause freezing of the sample liquid in the sample vessel; b) placing the thermal curve sample vessel defined by at least the top and bottom walls of the shipping container In the product cavity; c) an active cooling device is in thermal communication with the cavity, whereby the cooling device is suitable for cooling the cavity when it is started, the absorption cooling device includes an absorber, and its position is convenient to disperse the absorption The heat generated in the device is outside the product cavity; d) the cooling device is started to start cooling the cavity; e) the transport container is transported from the first position to the second location; and f) is removed from the cavity this product.

於本文所述另一實施例中，係提供用於運送複數個小於1ml樣本器皿之方法，該方法包括：運送以陣列架構容納該複數個小於1ml樣本器皿之熱控制容器，其中各器皿以自由流動、非吸收形態容納其大多數樣本，且其中器皿放置形式為，各容器中至少兩個器皿與各對象相關聯，其中至少第一樣本於基質中包括第一抗凝劑，第二樣本於基質中包括第二抗凝劑。 In another embodiment described herein, a method for transporting a plurality of sample vessels of less than 1 ml is provided. The method includes: transporting a thermal control container containing the plurality of sample vessels of less than 1 ml in an array structure, wherein each vessel is free The mobile, non-absorbent form accommodates most of its samples, and the vessel is placed in the form that at least two vessels in each container are associated with each object, wherein at least the first sample includes the first anticoagulant in the matrix, and the second sample The second anticoagulant is included in the matrix.

應暸解，本文所述之任一實施例可適於具有一個或多個以下特徵。於一個非限制性實例中，體液樣本為血液。可選地，此體液樣本為毛細管血。可選地，體液樣本採集包括於對象上作出至少一次穿刺，以釋放體液，其中該穿刺不是靜脈穿刺。可選地，採集包括使用至少一個微針於對象上作出至少一次穿刺。可選地，採集包括使用至少一把柳葉刀於對象上作出至少一次穿刺。可選地，該穿刺經由刺手指完成。可選地，該穿刺經由刺對象之前臂皮膚完成。可選地，該穿刺經由刺對象之四肢之一上的皮膚完成。可選地，所述表面為對象皮膚。可選地，樣本器皿具有最初處於次大氣壓之內部。可選地，該次大氣壓至少為部分真空。可選地，此樣本器皿內部處於至少為低於環境氣壓之次大氣壓。可選地，選用該次大氣壓以提供將所需體積樣本抽取入樣本器皿之充足吸力。可選地，運送容器包含至少五個或更多樣本器皿。可選地，運送容器運送採自複數個不同對象之體液樣本。可選地，與各樣本器皿相關之資訊確定將對其中體液樣本進行何種測試。可選地，運送容器於運輸中被置於另一容器中。可選地，該方法於運輸至第二位置前，還於樣本器皿中包括處理前樣本。 It should be understood that any of the embodiments described herein may be adapted to have one or more of the following features. In one non-limiting example, the body fluid sample is blood. Optionally, the body fluid sample is capillary blood. Optionally, the body fluid sample collection includes making at least one puncture on the subject to release the body fluid, wherein the puncture is not a venipuncture. Optionally, the acquisition includes at least one puncture on the subject using at least one microneedle. Optionally, the collection includes at least one puncture on the subject using at least one lancet. Optionally, the puncture is done by puncturing the fingers. Optionally, the puncture is done by puncturing the skin of the forearm of the subject. Optionally, the puncture is done by puncturing the skin on one of the limbs of the subject. Optionally, the surface is the subject's skin. Optionally, the sample vessel has an interior that is initially at sub-atmospheric pressure. Optionally, the sub-atmospheric pressure is at least a partial vacuum. Optionally, the inside of the sample vessel is at least sub-atmospheric pressure below ambient pressure. Optionally, the subatmospheric pressure is selected to provide sufficient suction to draw the required volume of sample into the sample vessel. Optionally, the shipping container contains at least five or more sample vessels. Optionally, the transport container transports body fluid samples collected from a plurality of different subjects. Optionally, the information related to each sample vessel determines what test will be performed on the body fluid sample therein. Optionally, the shipping container is placed in another container during transportation. Optionally, the method includes a pre-treatment sample in the sample vessel before being transported to the second location.

可選地，容器之樣本器皿陣列密度係為每平方英寸至少約4個器皿。可選地，運送容器中一冷卻表面為容器中樣本器皿提供位於所需範圍內之溫度特徵。可選地，樣本器皿為可個別定址。可選地，該方法還包括於將 器皿載入容器前，使用經冷卻托盤容置樣本器皿於冷卻室中，並使用同一托盤將樣本器皿維持於容器中，其中樣本與經冷卻托盤一起被置於此容器中。可選地，樣本器皿放置形式使得各容器具有至少兩個器皿裝有採自同一對象之體液樣本，其中至少第一樣本於基質中包括第一抗凝劑，第二樣本於基質中包括第二抗凝劑。可選地，液體樣本包括用於CLIA合規實驗室測試之毛細管血。可選地，液體樣本包括用於CLIA合規實驗室測試之血液。可選地，提供受控熱特徵及高融解熱材料之外殼具有至少一個面向容器之冷卻表面。可選地，用於製備容器之材料中嵌入有一種高融解熱材料。可選地，具有約30%至50%之一種受控熱特徵及高融解熱材料。可選地，具有約10%至30%之一種受控熱特徵及高融解熱材料。可選地，該方法還包括由金屬材料製成之外殼，其靜止溫度低於環境溫度。 Optionally, the sample vessel array density of the container is at least about 4 vessels per square inch. Optionally, a cooling surface in the shipping container provides the sample vessel in the container with a temperature characteristic within a desired range. Optionally, the sample vessels are individually addressable. Optionally, the method also includes Before the vessel is loaded into the container, the cooled tray is used to hold the sample vessel in the cooling chamber, and the same tray is used to maintain the sample vessel in the container, wherein the sample is placed in this container together with the cooled tray. Optionally, the sample vessels are placed in a form such that each container has at least two vessels containing body fluid samples collected from the same subject, wherein at least the first sample includes the first anticoagulant in the matrix and the second sample includes the first Second anticoagulant. Optionally, the liquid sample includes capillary blood for CLIA compliance laboratory testing. Optionally, the liquid sample includes blood for CLIA compliance laboratory testing. Optionally, the housing providing controlled thermal characteristics and high melting heat material has at least one cooling surface facing the container. Optionally, a high melting heat material is embedded in the material used to prepare the container. Optionally, it has a controlled thermal characteristic of about 30% to 50% and a high melting heat material. Optionally, it has a controlled thermal characteristic of about 10% to 30% and a high melting heat material. Optionally, the method further includes an outer shell made of a metal material whose static temperature is lower than the ambient temperature.

可選地，該方法還包括於接收地點掃描各樣本上之資訊儲存單元，並自動將容器放入匣中。可選地，該方法還包括於接收地點掃描各樣本上之資訊儲存單元，並自動將容器放入匣中。並自動將容器放入匣中。可選地，該方法還包括於運送前放置在冷藏裝置中及於運送過程中放置在運送容器中時，使用同一托盤以陣列架構放置樣本器皿。可選地，該方法還包括使用由一種高度熱傳導材料構成之托盤容置樣本器皿。可選地，該托盤具有複數個槽，其形狀可以優選方位容置樣本器皿支架。可選地，此托盤被配置為直接與樣本器皿支架接合。可選地，使用托 盤鎖定機構於容器中固定托盤，其中該托盤鎖定機構僅籍由施加磁力方釋放托盤。可選地，該方法包括於運送過程中將溫度範圍維持於2至8C。可選地，該方法還包括一種溫度控制材料，其於運送過程中維持高於冷凍溫度，惟低於約10C。可選地，該方法包括使用溫度門檻值檢測器指示樣本器皿是否達到超出門檻值程度的溫度。可選地，該方法還包括與運送前掃描托盤中的器皿，以確定是否有樣本處理步驟未曾完成；使用處理器執行或再次執行某一步驟。可選地，該方法還包括將樣本器皿一步載入托盤中，隨後將托盤一步載入運送容器中。 Optionally, the method further includes scanning the information storage unit on each sample at the receiving location and automatically placing the container in the cassette. Optionally, the method further includes scanning the information storage unit on each sample at the receiving location and automatically placing the container in the cassette. And automatically put the container into the box. Optionally, the method further includes using the same tray to place the sample vessels in an array structure when placed in a refrigerated device before shipping and placed in a shipping container during shipping. Optionally, the method also includes using a tray made of a highly thermally conductive material to hold the sample vessels. Optionally, the tray has a plurality of grooves, and the shape of the tray can be preferably oriented to receive the sample vessel holder. Optionally, this tray is configured to directly engage the sample vessel holder. Optionally, use The disk locking mechanism fixes the tray in the container, wherein the tray locking mechanism only releases the tray by applying magnetic force. Optionally, the method includes maintaining a temperature range of 2 to 8C during transportation. Optionally, the method also includes a temperature control material that is maintained above the freezing temperature during transport, but below about 10C. Optionally, the method includes using a temperature threshold detector to indicate whether the sample vessel has reached a temperature that exceeds the threshold. Optionally, the method further includes scanning the vessel in the tray with the pre-delivery method to determine whether any sample processing step has not been completed; using a processor to perform or perform a certain step again. Optionally, the method further includes loading the sample vessel into the tray in one step, and then loading the tray into the shipping container in one step.

可選地，運送容器具有第一表面，其被配置為限定通向容器中受控熱特徵及高融解熱材料之熱傳導路徑。可選地，該第一表面被配置為與經吸收冷卻裝置冷卻之另一表面直接接觸。可選地，該方法包括對托盤中樣本器皿同時進行條碼掃描。可選地，該方法包括對托盤中樣本器皿底部同時進行條碼掃描。可選地，該方法包括對樣本器皿按行進行條碼掃描。可選地，該方法包括對樣本器皿按行進行底部條碼掃描。可選地，該方法包括以倒置方位運送複數個樣本器皿。可選地，該方法包括運送複數個樣本器皿，其中血細胞及血漿被樣本器皿中一種阻隔材料分開。可選地，該方法包括籍由開鎖及打開步驟打開容器，其中至少一個鉸鏈將兩片連於一起。可選地，托盤具有至少一個磁接觸點用於將托盤從容器上移除。可選地，運用電腦控制末端效應器將樣本器皿載入運送容器和/或 從其中卸除，其中於卸除前、過程中或之後，讀出器自附於一個或多個樣本器皿上之至少一個資訊儲存單元獲取資訊。 Optionally, the shipping container has a first surface that is configured to define a thermal conduction path to the controlled thermal features and high melting heat material in the container. Optionally, the first surface is configured to directly contact another surface cooled by the absorption cooling device. Optionally, the method includes simultaneous barcode scanning of the sample vessels in the tray. Optionally, the method includes simultaneous barcode scanning on the bottom of the sample vessel in the tray. Optionally, the method includes scanning the sample vessels line by line. Optionally, the method includes performing a bottom bar code scan on the sample vessels in rows. Optionally, the method includes transporting a plurality of sample vessels in an inverted orientation. Optionally, the method includes transporting a plurality of sample vessels, in which blood cells and plasma are separated by a barrier material in the sample vessels. Optionally, the method includes opening the container by the steps of unlocking and opening, wherein at least one hinge connects the two pieces together. Optionally, the tray has at least one magnetic contact point for removing the tray from the container. Optionally, a computer controlled end effector is used to load the sample vessel into the shipping container and / or Dismounting from it, wherein before, during or after removal, the reader acquires information from at least one information storage unit attached to one or more sample vessels.

於本文所述又一實施例中，係提供有熱控制運送容器用於運送複數個樣本器皿，該運送容器包括：具有至少頂壁、底壁及側壁以共同限定一空腔之容器，其中所述頂壁、底壁及側壁中至少之一個包括相變材料；框架，其尺寸適合進入該空腔，其上限定有被配置為容納複數個樣本器皿之開口，並具有被配置為於樣本器皿側壁接觸之側壁，其中容器放置形式為各病患有至少第一樣本於基質中包括第一抗凝劑及第二樣本於基質中包括第二抗凝劑。 In yet another embodiment described herein, a thermally controlled transport container is provided for transporting a plurality of sample vessels. The transport container includes: a container having at least a top wall, a bottom wall, and a side wall to collectively define a cavity, wherein the At least one of the top wall, the bottom wall, and the side wall includes a phase change material; the frame is sized to enter the cavity, defines an opening configured to receive a plurality of sample vessels, and has a side wall configured to the sample vessel The contacting side wall, wherein the container is placed in such a manner that at least the first sample includes the first anticoagulant in the matrix and the second sample includes the second anticoagulant in the matrix.

於本文所述另一實施例中，係提供有熱控制運送容器用於運送複數個樣本器皿，該運送容器包括：a)底容器部分，其具有底壁及至少一個第一側壁以限定適合於其中容納產品之空腔；b)頂容器部分，其具有頂面及底面，並適合與所述底容器部分結合以限定產品空腔，該頂容器部分形成該容器之頂壁，其中所述頂壁、底壁及側壁中至少之一個包括相變材料。 In another embodiment described herein, a thermally controlled transport container is provided for transporting a plurality of sample vessels. The transport container includes: a) a bottom container portion having a bottom wall and at least one first side wall to define A cavity in which the product is contained; b) a top container portion, which has a top surface and a bottom surface, and is suitable for combining with the bottom container portion to define a product cavity, the top container portion forming a top wall of the container, wherein At least one of the wall, the bottom wall, and the side wall includes a phase change material.

於本文所述另一實施例中，係提供有熱控制運送容器用於運送複數個樣本器皿，該運送容器包括：a)底容器部分，其具有底壁及至少一個第一側壁以限定適合於其中容納產品之空腔；b)頂容器部分，其具有頂面及底面，並適合與所述底容器部分結合以限定產品空腔，該頂容器部分形成該容器之頂壁；c)用於限定複數個樣本器皿 容置空間之支架，以將樣本器皿定位於一個預定方位；其中所述頂壁、底壁及側壁中至少之一個包括相變材料。 In another embodiment described herein, a thermally controlled transport container is provided for transporting a plurality of sample vessels. The transport container includes: a) a bottom container portion having a bottom wall and at least one first side wall to define a suitable The cavity in which the product is contained; b) the top container part, which has a top surface and a bottom surface, and is suitable for combining with the bottom container part to define a product cavity, the top container part forming the top wall of the container; c) Limited number of sample vessels A bracket for accommodating the space to position the sample vessel in a predetermined orientation; wherein at least one of the top wall, the bottom wall, and the side wall includes a phase change material.

於本文所述另一實施例中，係提供用於運送樣本器皿之容器，該容器包括：大致成矩形之底板；從該底板縱向邊緣伸出之大致平行的側板；從底板頂端邊緣伸出且橋接側邊之大致平行的頂端；可置於側板和頂端之上，並於其及底板形成大致封閉空間的蓋；於容器內部可移除地與底板連接之樣本器皿支架，其被配置為限定器皿容置空間。可選地，此器皿容置空間被配置為容置具有約2ml或更小內部體積之抽氣血樣採集試管。 In another embodiment described herein, a container for transporting a sample vessel is provided, the container including: a substantially rectangular bottom plate; a substantially parallel side plate extending from a longitudinal edge of the bottom plate; extending from a top edge of the bottom plate and The generally parallel top ends bridging the side edges; can be placed on the side plates and the top ends, and form a generally closed space cover on the bottom plate; a sample vessel holder removably connected to the bottom plate inside the container, which is configured to define Utensils accommodating space. Optionally, this vessel accommodating space is configured to accommodate an evacuated blood sample collection test tube having an internal volume of about 2 ml or less.

於本文所述另一實施例中，係提供有熱控制運送容器用於運送複數個樣本器皿，該運送容器包括：以至少一個固定方位容置複數個樣本器皿之構件；用於將樣本器皿穩定熱控制於所需之0至10C範圍內的構件；其中用於容置複數個樣本器皿之構件可從運送容器中移去。可選地，器皿容置空間被配置為容置具有約2ml或更小內部體積之抽氣血樣採集試管。 In another embodiment described herein, a thermally controlled transport container is provided for transporting a plurality of sample vessels. The transport container includes: a member for accommodating a plurality of sample vessels in at least one fixed orientation; for stabilizing the sample vessels Components whose heat is controlled within the required range of 0 to 10C; the components used to accommodate a plurality of sample vessels can be removed from the shipping container. Optionally, the vessel accommodating space is configured to accommodate an evacuated blood sample collection test tube having an internal volume of about 2 ml or less.

應暸解，一些實施例可具有包括任何上述運送容器之套件。可選地，該套件包括運送容器及其使用說明。 It should be appreciated that some embodiments may have a kit that includes any of the aforementioned shipping containers. Optionally, the kit includes a shipping container and instructions for its use.

於本文所述一個實施例中，係說明用於從發送者提供全血樣本和/或其部分至接收者之方法。該方法包括：運送包括具有一個或多個通道之樣本器皿的組件，該組件容納(a)體積小於或等於約200微升(ul)的液體形態全 血樣本和/或其部分及(b)用於保存全血樣本和/或其部分中一種或多種分析物之一種或多種試劑，直至至少當全血樣本和/或其部分抵達接收者時進行分析，且其中交付使樣本器皿得以投遞給接收者。作為非限制性實例，可藉由使用包裹遞送服務、快件或其它運送服務運送樣本器皿。 In one embodiment described herein, a method for providing a whole blood sample and / or part thereof from a sender to a recipient is described. The method includes: transporting an assembly including a sample vessel having one or more channels, the assembly containing (a) a liquid having a volume less than or equal to about 200 microliters (ul) Blood sample and / or part thereof and (b) one or more reagents for storing one or more analytes in the whole blood sample and / or part thereof until at least when the whole blood sample and / or part thereof reaches the recipient Analysis, and delivery therein allows sample vessels to be delivered to the recipient. As a non-limiting example, the sample vessel can be shipped by using a package delivery service, courier or other shipping service.

於本文所述一個實施例中，係說明用於準備全血樣本以便遞交至樣本處理站之方法。該方法包括：將含有體積小於或等於約200ul之液體形態全血樣本的樣本器皿交付給遞送服務公司，以便將該樣本器皿投遞給樣本處理站處理該全血樣本。樣本器皿之準備可藉由以下方法完成：(a)借助毛細管道從對象抽取全血樣本，及(b)將全血樣本置於樣本器皿中，其中使用容納於毛細管道和/或樣本器皿中的一種或多種試劑保存該全血樣本於液體形態。 In one embodiment described herein, a method for preparing a whole blood sample for submission to a sample processing station is described. The method includes: delivering a sample vessel containing a liquid form whole blood sample whose volume is less than or equal to about 200 ul to a delivery service company, so that the sample vessel is delivered to a sample processing station to process the whole blood sample. The preparation of the sample vessel can be accomplished by the following methods: (a) drawing a whole blood sample from the subject via the capillary channel, and (b) placing the whole blood sample in the sample vessel, which is contained in the capillary channel and / or sample vessel One or more reagents to save the whole blood sample in liquid form.

應暸解，本文所述之任一實施例可適於具有一個或多個以下特徵。作為非限制性實例，一些實施例中樣本可為半固態或凝膠態。這可於樣本已處於樣本器皿中時發生。可選地，遞送服務公司為郵件遞送服務公司。可選地，血液樣本於護理地點採集自對象。可選地，該護理地點為對象的家。可選地，該護理地點為保健業者地點。 It should be understood that any of the embodiments described herein may be adapted to have one or more of the following features. As a non-limiting example, in some embodiments the sample may be in a semi-solid or gel state. This can happen when the sample is already in the sample vessel. Optionally, the delivery service company is a mail delivery service company. Optionally, blood samples are collected from the subject at the care site. Optionally, the care location is the subject's home. Optionally, the care location is a health care provider location.

於本文所述另一實施例中，一種用於處理全血樣本之方法包括於處理站自包裹送遞服務接收含有體積小於或等於約200ul之全血樣本的樣本器皿，其中於處理站接收之樣本器皿其全血樣本處於液態；並於處理站對液體 形態全血樣本執行至少一種預分析和/或分析。 In another embodiment described herein, a method for processing a whole blood sample includes receiving a sample vessel containing a whole blood sample having a volume less than or equal to about 200 ul from a package delivery service at a processing station, wherein The whole blood sample of the sample vessel is in liquid state; The morphological whole blood sample performs at least one pre-analysis and / or analysis.

應暸解，本文所述之任一實施例可適於具有一個或多個以下特徵。作為非限制性實例，此分析具有一個或多個步驟。可選地，樣本器皿被包括於具有一個或多個環境控制區域之外殼中。可選地，此外殼適於控制各環境控制區域之濕度。可選地，此外殼適於控制各環境控制區域之壓力。 It should be understood that any of the embodiments described herein may be adapted to have one or more of the following features. As a non-limiting example, this analysis has one or more steps. Optionally, the sample vessel is included in a housing with one or more environmental control areas. Optionally, the enclosure is suitable for controlling the humidity in various environmental control areas. Optionally, the housing is suitable for controlling the pressure in each environmental control area.

於本文所述又一實施例中，係提供有一種於處理站將血樣排隊以便處理之電腦執行方法。該方法包括(a)採用具有電腦處理器之地理定位系統識別帶有該血樣之樣本器皿的地理位置；(b)採用電腦處理器估計該樣本器皿抵達處理站之遞交時間；及(c)基於所估計之遞交時間，提供預備工作通知，以便於處理站處理該樣本。 In yet another embodiment described herein, a computer-implemented method for queuing blood samples for processing at a processing station is provided. The method includes (a) using a geolocation system with a computer processor to identify the geographic location of the sample vessel with the blood sample; (b) using a computer processor to estimate the delivery time of the sample vessel to the processing station; and (c) based on The estimated delivery time provides a preliminary work notice to facilitate the processing station to process the sample.

於本文所述又一實施例中，係說明了一種準備全血樣本以遞交至樣本處理站之方法。該方法包括將帶有液體形態全血樣本之樣本器皿交付給遞送服務公司，以便將該樣本器皿投遞給樣本處理站處理該全血樣本，其中該樣本器皿準備方式為(a)使用一種器械從對象抽取全血樣本，及(b)將全血樣本置於樣本器皿中。 In yet another embodiment described herein, a method of preparing a whole blood sample for submission to a sample processing station is described. The method includes delivering a sample vessel with a whole blood sample in liquid form to a delivery service company to deliver the sample vessel to a sample processing station for processing the whole blood sample, wherein the sample vessel preparation method is (a) using a device from The subject draws a whole blood sample, and (b) places the whole blood sample in a sample vessel.

可選地，交付可包括提取和/或留下。可選地，處理可包括分析前處理、分析處理及分析後處理。可選地，遞送服務公司可包括對象之遞送服務公司或第三方遞送服務公司。可選地，可使用容納於毛細管道或樣本器皿中的一種或多種試劑保存該全血樣本於液體形態。 Alternatively, delivery may include extraction and / or retention. Alternatively, the processing may include pre-analysis processing, analytical processing, and post-analysis processing. Alternatively, the delivery service company may include a target delivery service company or a third-party delivery service company. Alternatively, one or more reagents contained in the capillary channel or sample vessel may be used to preserve the whole blood sample in liquid form.

於本文所述又一實施例中，係提供有一種於樣本處理站處理全血樣本之方法。該方法包括於處理站自送遞服務公司接收含有全血樣本之樣本器皿，其中該樣本器皿準備方式為(a)使用一種採集器械從對象抽取全血樣本，及(b)將全血樣本置於樣本器皿中。該方法亦包括於處理站對全血樣本執行至少一種預分析或分析 In yet another embodiment described herein, a method for processing a whole blood sample at a sample processing station is provided. The method includes receiving a sample vessel containing a whole blood sample from a delivery service company at a processing station, wherein the sample vessel is prepared by (a) using a collection device to draw a whole blood sample from a subject, and (b) placing the whole blood sample In the sample vessel. The method also includes performing at least one pre-analysis or analysis on the whole blood sample at the processing station

應暸解，本文所述之任一實施例可適於具有一個或多個以下特徵。作為非限制性實例，採用電腦處理器提供自估計遞交時間起完成處理時間。可選地，該方法係包括於估計交付樣本器皿至處理站之時間起將樣本器皿排隊以便處理。可選地，採用通訊網路識別樣本器皿之地理位置。 It should be understood that any of the embodiments described herein may be adapted to have one or more of the following features. As a non-limiting example, a computer processor is used to provide completion time from the estimated delivery time. Optionally, the method includes queuing the sample vessels for processing from the estimated time of delivery of the sample vessels to the processing station. Optionally, a communication network is used to identify the geographic location of the sample vessel.

於本文所述一個實施例中，係說明有一種用於提供完成血樣處理之估計時間的電腦執行方法。該方法包括接收有關經由遞送服務公司運送至處理站以進行樣本處理之樣本器皿的資訊，該樣本器皿具有取自對象之血樣。該方法亦包括採用電腦處理器計算處理站之處理排程中該血樣之位置，其中該預報乃是基於(i)有關此處理排程中採自其他對象之血樣位置之資訊，及(ii)有關容納有採自其他對象之血樣的其它樣本器皿相對於容納有採自對象之血樣的該樣本器皿之地理位置的資訊。該方法包括預報遞送服務公司將樣本器皿交付至處理站之後於處理站處理血樣的時間；並基於該預報及向處理站交付樣本器皿之估計時間，向對象或與對象相關之保健業者提供處理採自該對 象之血樣估計所需時間，該估計時間自樣本器皿交付遞送服務公司之時間點起算。可選地，樣本被運送至複數個處理站。應暸解，可廣義解釋本文所述之處理，即可包括分析前、分析和/或分析後步驟。 In one embodiment described herein, a computer-implemented method for providing an estimated time to complete blood sample processing is described. The method includes receiving information about a sample vessel transported to a processing station for sample processing by a delivery service company, the sample vessel having a blood sample taken from a subject. The method also includes using a computer processor to calculate the location of the blood sample in the processing schedule of the processing station, where the forecast is based on (i) information about the location of blood samples collected from other objects in the processing schedule, and (ii) about containment There is information on the geographic location of other sample vessels collected from blood samples of other subjects relative to the sample vessel containing blood samples collected from subjects. The method includes predicting the time at which the delivery service company delivers the sample vessel to the processing station to process the blood sample at the processing station; and based on the forecast and the estimated time to deliver the sample vessel to the processing station, provide the subject or a healthcare provider related to the subject with the treatment sample Since the pair The estimated time of the blood sample is calculated from the time when the sample vessel is delivered to the delivery service company. Optionally, the sample is transported to a plurality of processing stations. It should be understood that the processing described herein can be broadly explained, that is, it can include pre-analysis, analysis, and / or post-analysis steps.

於本文所述又一實施例中，係說明有一種電腦執行方法，用於提供完成採自對象之血樣處理的估計時間。該方法包括接收有關經由遞送服務公司運送至處理站以進行樣本處理之樣本器皿的資訊，該樣本器皿具有取自對象之血樣。該方法亦包括採用電腦處理器計算處理站之處理排程中該血樣之位置，其中該預報乃是基於(i)有關此處理排程中採自其他對象之血樣位置之資訊，及(ii)有關容納有採自其他對象之血樣的其它樣本器皿相對於容納有採自對象之血樣的該樣本器皿之地理位置的資訊。該方法包括預報遞送服務公司將樣本器皿交付至處理站之後於處理站處理血樣的時間；並基於該預報及向處理站交付樣本器皿之估計時間，於處理站分配一種或多種資源用於血樣被交付至處理站後處理該血樣。 In yet another embodiment described herein, it is illustrated that there is a computer-implemented method for providing an estimated time to complete processing of a blood sample collected from a subject. The method includes receiving information about a sample vessel transported to a processing station for sample processing by a delivery service company, the sample vessel having a blood sample taken from a subject. The method also includes using a computer processor to calculate the location of the blood sample in the processing schedule of the processing station, where the forecast is based on (i) information about the location of blood samples collected from other objects in the processing schedule, and (ii) about containment There is information on the geographic location of other sample vessels collected from blood samples of other subjects relative to the sample vessel containing blood samples collected from subjects. The method includes predicting the time when the delivery service company delivers the sample vessel to the processing station to process the blood sample at the processing station; and based on the forecast and the estimated time to deliver the sample vessel to the processing station, allocating one or more resources for the blood sample at the processing station The blood sample is processed after delivery to the processing station.

應暸解，本文所述之任一實施例可適於具有一個或多個以下特徵。作為非限制性實例，樣本器皿具有資訊儲存單元，可藉由遞送服務公司和/或處理位置識別樣本器皿。可選地，此資訊儲存單元為射頻識別(RFID)標籤。可選地，此資訊儲存單元為條碼。可選地，此資訊儲存單元為微晶片。可選地，樣本器皿包括一個或多個傳感器用於採集血樣之一個或多個溫度、樣本器皿之壓力、 血樣pH值、血樣濁度、血樣黏度等。可選地，處理位置應需處理所採集的血樣。可選地，樣本器皿包括地理位置裝置以提供樣本器皿之位置。可選地，抗凝劑選自肝磷脂、EDTA、某種抗凝劑或其它添加劑。可選地，其中器皿容置空間被配置為容置抽氣血樣採集試管之容器被配置為容置具有至多約60%真空之部分真空的抽氣血樣採集試管 It should be understood that any of the embodiments described herein may be adapted to have one or more of the following features. As a non-limiting example, the sample vessel has an information storage unit, which can be identified by the delivery service company and / or processing location. Optionally, the information storage unit is a radio frequency identification (RFID) tag. Optionally, this information storage unit is a barcode. Optionally, the information storage unit is a microchip. Optionally, the sample vessel includes one or more sensors for collecting one or more temperatures of the blood sample, the pressure of the sample vessel, Blood sample pH, blood sample turbidity, blood sample viscosity, etc. Optionally, the processing location should process the collected blood samples. Optionally, the sample vessel includes a geographic location device to provide the position of the sample vessel. Optionally, the anticoagulant is selected from heparin, EDTA, some anticoagulant or other additives. Optionally, the container in which the container accommodating space is configured to accommodate the evacuated blood sample collection test tube is configured to accommodate the evacuated blood sample collection test tube with a partial vacuum of at most about 60% vacuum

於本文所述包括第一器皿及第二器皿之實施例中，於特定實施例中，所述第一器皿及第二器皿之內部體積各為1000、750、500、400、300、250、200、150、100、90、80、70、60、50、40、30、25、20、15、10、9、8、7、6、5、4、3、2微升或更小。於本文所述包括第一器皿及第二器皿之實施例中，於特定實施例中，所述第一器皿及第二器皿之內部體積均不超過1000、750、500、400、300、250、200、150、100、90、80、70、60、50、40、30、25、20、15、10、9、8、7、6、5、4、3或2微升。於本文所述包括一個或多個器皿之實施例中，於特定實施例中，所述一個或多個器皿之內部體積各為1000、750、500、400、300、250、200、150、100、90、80、70、60、50、40、30、25、20、15、10、9、8、7、6、5、4、3、2微升或更小。於本文所述包括一個或多個器皿之實施例中，於特定實施例中，所述一個或多個器皿之內部體積均不超過1000、750、500、400、300、250、200、150、100、90、80、70、 60、50、40、30、25、20、15、10、9、8、7、6、5、4、3或2微升。 In the embodiments described herein including the first vessel and the second vessel, in a specific embodiment, the internal volume of the first vessel and the second vessel are each 1000, 750, 500, 400, 300, 250, 200 , 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 microliters or less. In the embodiments described herein including the first vessel and the second vessel, in a specific embodiment, the internal volume of the first vessel and the second vessel does not exceed 1000, 750, 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3 or 2 microliters. In the embodiments described herein including one or more vessels, in specific embodiments, the internal volume of the one or more vessels is each 1000, 750, 500, 400, 300, 250, 200, 150, 100 , 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2 microliters or less. In the embodiments described herein including one or more vessels, in a specific embodiment, the internal volume of the one or more vessels does not exceed 1000, 750, 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3 or 2 microliters.

於本文所述包括第一器皿及第二器皿之實施例中，各包含小體積體液樣本之一部分，於特定實施例中，所述第一器皿及第二器皿之均不包含該小體積體液樣本之一部分，該小體積體液樣本具有之體積大於500、400、300、250、200、150、100、90、80、70、60、50、40、30、25、20、15、10、9、8、7、6、5、4、3或2微升。 In the embodiment described herein that includes the first vessel and the second vessel, each includes a portion of a small volume of body fluid sample. In a specific embodiment, neither of the first vessel nor the second vessel includes the small volume of body fluid sample. Part, the small volume of the body fluid sample has a volume greater than 500, 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3 or 2 microliters.

於本文所述包括包含體液樣本之一個或多個器皿的實施例中，於特定實施例中，所述一個或多個器皿中至少一個包含填充該器皿內部體積至少99、98、97、96、95、90、85、80、75、70、60、50、40、30、20、10或5%之體液樣本。於本文所述包括包含體液樣本之一個或多個器皿的實施例中，於特定實施例中，所述一個或多個器皿中每一個包含填充該器皿內部體積至少99、98、97、96、95、90、85、80、75、70、60、50、40、30、20、10或5%之體液樣本。 In the embodiments described herein that include one or more vessels containing a sample of body fluid, in particular embodiments, at least one of the one or more vessels includes filling at least 99, 98, 97, 96, 95, 90, 85, 80, 75, 70, 60, 50, 40, 30, 20, 10 or 5% body fluid samples. In the embodiments described herein that include one or more vessels containing body fluid samples, in particular embodiments, each of the one or more vessels includes filling at least 99, 98, 97, 96, 95, 90, 85, 80, 75, 70, 60, 50, 40, 30, 20, 10 or 5% body fluid samples.

於本文所述包括樣本採集地點及樣本接收地點之實施例中，於實施例中，該樣本採集地點及樣本接收地點可處於同一房間、建築物、場地或建築物群中。於本文所述包括樣本採集地點及樣本接收地點之實施例中，於實施例中，該樣本採集地點及樣本接收地點可處於不同房間、建築物、場地或建築物群中。於實施例中，該樣本採 集地點及樣本接收地點可分隔至少1米、5米、10米、50米、100米、500米、1公里、5公里、10公里、15公里、20公里、30公里、50公里、100公里或500公里。於實施例中，該樣本採集地點及樣本接收地點可分隔不超過5米、10米、50米、100米、500米、1公里、5公里、10公里、15公里、20公里、30公里、50公里、100公里、500公里或1000公里。於實施例中，該樣本採集地點及樣本接收地點可分隔至少1米、5米、10米、50米、100米、500米、1公里、5公里、10公里、15公里、20公里、30公里、50公里、100公里或500公里且不超過5米、10米、50米、100米、500米、1公里、5公里、10公里、15公里、20公里、30公里、50公里、100公里、500公里或1000公里。於實施例中，本文所述第一位置可為樣本採集地點，且本文所述第二位置可為樣本接收地點。 In the embodiments described herein that include a sample collection location and a sample reception location, in an embodiment, the sample collection location and the sample reception location may be in the same room, building, site, or group of buildings. In the embodiments described herein that include a sample collection location and a sample reception location, in an embodiment, the sample collection location and the sample reception location may be in different rooms, buildings, venues, or groups of buildings. In the embodiment, the sample is taken The collection location and sample receiving location can be separated by at least 1 m, 5 m, 10 m, 50 m, 100 m, 500 m, 1 km, 5 km, 10 km, 15 km, 20 km, 30 km, 50 km, 100 km Or 500 kilometers. In an embodiment, the sample collection location and the sample reception location can be separated by no more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometers, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 kilometers, 500 kilometers or 1000 kilometers. In an embodiment, the sample collection location and the sample reception location can be separated by at least 1 m, 5 m, 10 m, 50 m, 100 m, 500 m, 1 km, 5 km, 10 km, 15 km, 20 km, 30 Kilometers, 50 kilometers, 100 kilometers or 500 kilometers and no more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometers, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 Kilometers, 500 kilometers or 1000 kilometers. In an embodiment, the first location described herein may be a sample collection location, and the second location described herein may be a sample reception location.

於本文所述包括包含自樣本採集地點運送至樣本接收地點之至少一部分小體積體液樣本之器皿的實施例中，於實施例中，該體液樣本可於器皿運送過程中被保持於液體形態。於本文所述包括兩個或更多個器皿之實施例中，各器皿包含自樣本採集地點運送至樣本接收地點之小體積體液樣本中至少一部分，於實施例中，各器皿中體液樣本可於器皿運送過程中被保持於液體形態。 In the embodiment described herein that includes a vessel containing at least a portion of a small volume of body fluid sample that is transported from the sample collection site to the sample receiving site, in an embodiment, the body fluid sample can be maintained in a liquid form during the vessel transport process. In the embodiments described herein that include two or more vessels, each vessel includes at least a portion of a small volume of body fluid sample that is transported from the sample collection site to the sample receiving site. In an embodiment, the body fluid sample in each vessel may be The vessel is kept in liquid form during transportation.

於本文所述包括包含自樣本採集地點運送至樣本接收地點之一個或多個器皿的實施例中，於實施例中，該一個或多個器皿可於運送容器中被運送。於本文所述包 括於運送容器中被運送之一個或多個器皿的實施例中，於實施例中，該一個或多個器皿可以陣列形式定位於運送容器中，且當從上往下觀察該陣列時，該陣列每平方英寸可包含至少1、2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、50或100個器皿。 In the embodiments described herein that include one or more vessels that are transported from the sample collection site to the sample reception site, in an embodiment, the one or more vessels can be transported in a transport container. Package described in this article Included in an embodiment of one or more vessels being transported in a shipping container, in an embodiment, the one or more vessels may be positioned in the shipping container in an array form, and when the array is viewed from above, the The array may contain at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, or 100 vessels per square inch.

於本文所述包括於運送容器中運送一個或多個器皿之實施例中，於實施例中，該運送容器可包含採自至少1、2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、50或100個不同對象之體液樣本。 In the embodiments described herein that include transporting one or more vessels in a transport container, in an embodiment, the transport container may include samples taken from at least 1, 2, 3, 4, 5, 6, 7, 8, 9 , 10, 15, 20, 25, 30, 35, 40, 50 or 100 different body fluid samples.

於本文所述包括包含至少一部分體液樣本之器皿的實施例中，於實施例中，該器皿可包含一種抗凝劑。於包括各包含一部分採自對象之體液樣本之兩個或更多個器皿的實施例中，於實施例中，所述器皿中至少一個或全部可包含一種抗凝劑。於實施例中，當各包含一部分採自對象之體液樣本之兩個或更多個器皿亦各包含一種抗凝劑時，所述器皿可包含相同抗凝劑或不同抗凝劑。器皿所含之抗凝劑可為，例如肝磷脂或EDTA。 In the embodiments described herein that include a vessel containing at least a portion of a body fluid sample, in an embodiment, the vessel may include an anticoagulant. In an embodiment including two or more vessels each containing a portion of a body fluid sample taken from a subject, in an embodiment, at least one or all of the vessels may include an anticoagulant. In an embodiment, when two or more vessels each containing a portion of a body fluid sample taken from a subject also contain an anticoagulant, the vessels may contain the same anticoagulant or different anticoagulants. The anticoagulant contained in the vessel may be, for example, heparin or EDTA.

於本文所述包括自樣本採集地點運送一個或多個器皿中之體液樣本至樣本接收地點之方法中，於實施例中，該體液樣本可於其從對象獲取後不超過48小時、36小時、24小時、16小時、12小時、8小時、7小時、6小時、5小時、4小時、3小時、2小時、60分鐘、45分鐘、30分鐘、20分鐘、15分鐘、10分鐘或5分鐘即抵達樣本接收地點。 In the method described herein that includes transporting a body fluid sample in one or more vessels from a sample collection site to a sample receiving site, in an embodiment, the body fluid sample may not exceed 48 hours, 36 hours, 24 hours, 16 hours, 12 hours, 8 hours, 7 hours, 6 hours, 5 hours, 4 hours, 3 hours, 2 hours, 60 minutes, 45 minutes, 30 minutes, 20 minutes, 15 minutes, 10 minutes or 5 minutes You will arrive at the sample receiving location.

於本文所述包括自樣本採集地點運送至少第一器皿至樣本接收地點之方法中，於實施例中，該方法還包括於運送第一器皿前將其離心處理。於本文所述包括自樣本採集地點運送複數個器皿至樣本接收地點之方法中，於實施例中，該方法還包括於運送該複數個器皿前將其離心處理。 In the method described herein that includes transporting at least the first vessel from the sample collection site to the sample receiving site, in an embodiment, the method further includes centrifuging the first vessel before transporting it. In the method described herein that includes transporting a plurality of containers from a sample collection site to a sample receiving location, in an embodiment, the method further includes centrifuging the plurality of containers before transporting them.

於本文所述包括自樣本採集地點運送至少第一器皿至樣本接收地點之方法中，於實施例中，於該樣本接收地點及將樣本自第一器皿中取出之前，該第一器皿被***具有自動液體處置儀器之樣本處理裝置中。於本文所述包括自樣本採集地點運送至少第一器皿及第二器皿至樣本接收地點之方法中，於實施例中，於該樣本接收地點及將樣本自第一器皿中取出之前，該第一器皿及第二器皿被***具有自動液體處置儀器之樣本處理裝置中。於實施例中，當容納有樣本之器皿被***具有自動液體處置儀器之樣本處理裝置中時，自動液體處置儀器可將樣本自該器皿中取出。於實施例中，於容納有樣本之器皿被***具有自動液體處置儀器之樣本處理裝置中之前，該器皿被***一個匣中，該匣隨後被***該樣本處理裝置中。一個匣可容置任意數目的容納有樣本之器皿，比如至少1、2、3、4、5、6、7、8、9、10、15、20、25、50或100個器皿。 In the method described herein that includes transporting at least a first vessel from a sample collection site to a sample receiving site, in an embodiment, before the sample receiving site and before removing the sample from the first vessel, the first vessel is inserted with In the sample processing device of the automatic liquid disposal instrument. In the method described herein that includes transporting at least the first vessel and the second vessel from the sample collection site to the sample receiving site, in an embodiment, before the sample receiving site and before removing the sample from the first vessel, the first The vessel and the second vessel are inserted into a sample processing device with an automatic liquid disposal instrument. In an embodiment, when a vessel containing a sample is inserted into a sample processing device with an automatic liquid handling instrument, the automatic liquid handling instrument can remove the sample from the vessel. In an embodiment, before the vessel containing the sample is inserted into the sample processing device with an automatic liquid disposal instrument, the vessel is inserted into a cassette, which is then inserted into the sample processing device. A cassette can hold any number of containers containing samples, such as at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 50, or 100 containers.

於實施例中，第一器皿中之體液樣本之一部分中一部分可為第一器皿原樣本之一部分或第一器皿稀釋樣本之一部分。於實施例中，第二器皿中之體液樣本之一部 分中一部分可為第二器皿原樣本之一部分或第二器皿稀釋樣本之一部分 In an embodiment, a part of a portion of the body fluid sample in the first vessel may be a part of the original sample of the first vessel or a part of the diluted sample of the first vessel. In an embodiment, a portion of the body fluid sample in the second vessel A part of the part may be a part of the original sample of the second vessel or a part of the diluted sample of the second vessel

此發明內容旨在以簡要形式介紹所選之概念，其將於下文實施方式中作詳細說明。此發明內容不應用以識別所申請主題之關鍵或必要特徵，亦不應用以限定所申請主題之實施範圍。 This summary of the invention aims to introduce the selected concepts in a brief form, which will be explained in detail in the following embodiments. This summary of the invention should not be used to identify key or essential features of the applied subject matter, nor should it be used to limit the scope of implementation of the applied subject matter.

經引用之結合 Cited combination

本發明說明中提及之全部出版物、專利及專利申請皆經由引用被結合於此，視同具體地、個別地指出各個別出版物、專利及專利申請經由引用被結合於此。 All publications, patents, and patent applications mentioned in the description of the present invention are incorporated herein by reference, and each individual publication, patent, and patent application is specifically and individually indicated to be incorporated herein by reference.

100‧‧‧樣本採集裝置 100‧‧‧Sample collection device

110‧‧‧蓋 110‧‧‧ cover

120‧‧‧本體 120‧‧‧Body

122a,122b‧‧‧通道 122a, 122b‧‧‧channel

130‧‧‧支架 130‧‧‧Bracket

140‧‧‧基座 140‧‧‧Dock

142a,142b‧‧‧指示器 142a, 142b‧‧‧ indicator

200‧‧‧樣本採集裝置 200‧‧‧Sample collection device

220‧‧‧本體 220‧‧‧Body

222a‧‧‧通道 222a‧‧‧channel

225‧‧‧通道 225‧‧‧channel

226‧‧‧樣本接收端 226‧‧‧Sample receiving end

228‧‧‧錐形部分 228‧‧‧Conical part

230‧‧‧支架 230‧‧‧Bracket

240‧‧‧基座 240‧‧‧Dock

300‧‧‧樣本採集裝置 300‧‧‧Sample collection device

320‧‧‧本體 320‧‧‧Body

322a,322b‧‧‧通道 322a, 322b‧‧‧channel

323a‧‧‧第一端 323a‧‧‧The first end

325a‧‧‧第二端 325a‧‧‧second end

326‧‧‧樣本接收端 326‧‧‧Sample receiving end

327a‧‧‧末端 327a‧‧‧End

327b‧‧‧末端 327b‧‧‧End

330‧‧‧支架 330‧‧‧Bracket

340‧‧‧基座 340‧‧‧Dock

342a,342b‧‧‧光學窗口 342a, 342b‧‧‧Optical window

346a,346b‧‧‧容器 346a, 346b‧‧‧Container

348a,348b‧‧‧蓋 348a, 348b‧‧‧ cover

349a,349b‧‧‧本體 349a, 349b‧‧‧Body

350‧‧‧通道支座 350‧‧‧channel support

352‧‧‧彈簧 352‧‧‧Spring

354‧‧‧轉接通道 354‧‧‧Transition channel

400‧‧‧樣本採集裝置 400‧‧‧Sample collection device

410‧‧‧蓋 410‧‧‧ cover

420‧‧‧本體 420‧‧‧Body

422a,422b‧‧‧通道 422a, 422b‧‧‧channel

423a,423b‧‧‧第一端 423a, 423b ‧‧‧ first end

425a,425b‧‧‧第二端；通道 425a, 425b ‧‧‧ second end; channel

426‧‧‧樣本接收端 426‧‧‧Sample receiving end

427a,427b‧‧‧末端 427a, 427b ‧‧‧ end

430‧‧‧支架 430‧‧‧Bracket

440‧‧‧基座 440‧‧‧Dock

442a,442b‧‧‧光學窗口 442a, 442b‧‧‧ optical window

446a,446b‧‧‧容器 446a, 446b‧‧‧Container

448a,448b‧‧‧蓋 448a, 448b‧‧‧ cover

449a,449b‧‧‧本體 449a, 449b‧‧‧Body

450‧‧‧通道支座 450‧‧‧channel support

452‧‧‧彈簧 452‧‧‧Spring

454‧‧‧轉接通道 454‧‧‧Transition channel

500‧‧‧樣本採集裝置 500‧‧‧Sample collection device

520‧‧‧本體 520‧‧‧Body

522a,522b‧‧‧採集路徑；通道 522a, 522b‧‧‧ acquisition path; channel

523a,523b‧‧‧第一端 523a, 523b ‧‧‧ first end

526‧‧‧樣本接收端 526‧‧‧Sample receiving end

527‧‧‧唇狀結構 527‧‧‧Lip structure

529‧‧‧內部 529‧‧‧Internal

530‧‧‧支架 530‧‧‧Bracket

532a,532b‧‧‧光學指示器 532a, 532b ‧‧‧ optical indicator

540‧‧‧基座 540‧‧‧Dock

542a,542b‧‧‧光學指示器 542a, 542b ‧‧‧ optical indicator

700‧‧‧樣本採集裝置 700‧‧‧Sample collection device

720‧‧‧本體 720‧‧‧Body

722a,722b‧‧‧通道 722a, 722b‧‧‧channel

723a,723b‧‧‧第一端 723a, 723b ‧‧‧ first end

729‧‧‧本體內部 729‧‧‧Internal body

730‧‧‧支架 730‧‧‧Bracket

732a,732b‧‧‧光學窗口 732a, 732b ‧‧‧ optical window

740‧‧‧基座 740‧‧‧Dock

742a,742b‧‧‧光學窗口 742a, 742b‧‧‧Optical window

746a,746b‧‧‧容器 746a, 746b‧‧‧Container

748a,748b‧‧‧蓋 748a, 748b‧‧‧ cover

749a,749b‧‧‧本體 749a, 749b‧‧‧Body

750‧‧‧通道支座 750‧‧‧channel support

752‧‧‧彈簧 752‧‧‧Spring

800‧‧‧樣本採集裝置 800‧‧‧Sample collection device

820‧‧‧本體 820‧‧‧Body

822a,822b‧‧‧通道 822a, 822b‧‧‧channel

830‧‧‧支架 830‧‧‧Bracket

832a,832b‧‧‧光學窗口 832a, 832b‧‧‧ optical window

840‧‧‧基座 840‧‧‧Dock

842a,842b‧‧‧光學窗口 842a, 842b‧‧‧ optical window

846a,846b‧‧‧容器 846a, 846b‧‧‧Container

848a,848b‧‧‧蓋 848a, 848b‧‧‧cover

849a,849b‧‧‧本體 849a, 849b‧‧‧Body

920‧‧‧本體 920‧‧‧Body

922a,922b‧‧‧通道 922a, 922b‧‧‧channel

930‧‧‧支架 930‧‧‧Bracket

940‧‧‧基座 940‧‧‧Dock

946a,946b‧‧‧容器 946a, 946b‧‧‧Container

950‧‧‧通道支座 950‧‧‧channel support

952‧‧‧彈簧 952‧‧‧Spring

954‧‧‧轉接通道 954‧‧‧Transition channel

1000‧‧‧樣本採集裝置 1000‧‧‧Sample collection device

1020‧‧‧本體 1020‧‧‧Body

1022a,1022b‧‧‧通道 1022a, 1022b‧‧‧channel

1030‧‧‧支架 1030‧‧‧Bracket

1040‧‧‧基座 1040‧‧‧Dock

1046a,1046b‧‧‧容器；光學指示器 1046a, 1046b‧‧‧ container; optical indicator

1100‧‧‧樣本採集裝置 1100‧‧‧Sample collection device

1102‧‧‧遠端 1102‧‧‧ Remote

1103,1104,1105,1106‧‧‧開口 1103,1104,1105,1106

1112,1114‧‧‧觀察窗口 1112,1114‧‧‧ Observation window

1120‧‧‧樣本填充部分 1120‧‧‧Sample filling part

1126,1128‧‧‧通道 1126,1128‧‧‧channel

1130‧‧‧支架 1130‧‧‧Bracket

1132,1134‧‧‧光學窗口 1132, 1134‧‧‧ optical window

1136‧‧‧唇狀部分 1136‧‧‧Lip part

1140‧‧‧基座 1140‧‧‧Dock

1146a,1146b‧‧‧容器 1146a, 1146b‧‧‧Container

1148a‧‧‧蓋 1148a‧‧‧cover

1150,1152‧‧‧轉接通道 1150,1152‧‧‧Transition channel

1156‧‧‧套管 1156‧‧‧Casing

1160‧‧‧樣本採集裝置 1160‧‧‧Sample collection device

1162,1164‧‧‧通道 1162,1164‧‧‧channel

1165‧‧‧共同進口路徑 1165‧‧‧Common import route

1166,1168‧‧‧樣本流特徵 1166,1168‧‧‧Sample stream characteristics

1170‧‧‧防交叉流動特徵；排氣口 1170‧‧‧Anti-cross flow characteristics; exhaust port

1172‧‧‧防交叉流動特徵；排氣口 1172‧‧‧Anti-cross flow characteristics; exhaust port

1174‧‧‧接合特徵 1174‧‧‧Joint features

1176‧‧‧變窄區域 1176‧‧‧Narrowed area

1182,1184‧‧‧通道 1182,1184‧‧‧channel

1186‧‧‧裝置進口之共同段 1186‧‧‧Common segment of device import

1188‧‧‧介面 1188‧‧‧Interface

1190,1194‧‧‧排氣口 1190,1194‧‧‧Exhaust

1200‧‧‧樣本採集裝置 1200‧‧‧Sample collection device

1202‧‧‧遠端 1202‧‧‧Far

1204‧‧‧樣本進入位置；開口 1204‧‧‧ sample entry position; opening

1210‧‧‧樣本採集裝置 1210‧‧‧Sample collection device

1212‧‧‧組織穿刺部件 1212‧‧‧Puncture parts

1214‧‧‧致動機制 1214‧‧‧Actuation mechanism

1216‧‧‧外殼 1216‧‧‧Housing

1220‧‧‧樣本採集裝置 1220‧‧‧Sample collection device

1222‧‧‧組織穿刺部件 1222‧‧‧Puncture parts

1224‧‧‧驅動機制 1224‧‧‧Drive mechanism

1230‧‧‧樣本採集裝置 1230‧‧‧Sample collection device

1232‧‧‧組織穿刺部件 1232‧‧‧Puncture parts

1233‧‧‧箭頭 1233‧‧‧arrow

1234‧‧‧發動按鈕 1234‧‧‧Start button

1235‧‧‧視覺指示器 1235‧‧‧ visual indicator

1236‧‧‧成型前端 1236‧‧‧Forming front

1242‧‧‧組織穿刺部件 1242‧‧‧Puncture parts

1250‧‧‧傷口產生裝置；從裝置 1250‧‧‧Wound generating device; slave device

1252‧‧‧組織穿刺部件 1252‧‧‧Puncture parts

1270‧‧‧真空源 1270‧‧‧Vacuum source

1280‧‧‧管頭 1280‧‧‧ tube head

1282,1284‧‧‧組織穿刺部件 1282,1284‧‧‧Puncture parts

1290‧‧‧裝置 1290‧‧‧ device

1291‧‧‧橫膈膜 1291‧‧‧ Diaphragm

1292‧‧‧組織穿刺部件 1292‧‧‧Puncture parts

1296‧‧‧容器 1296‧‧‧Container

1300‧‧‧樣本採集裝置 1300‧‧‧Sample collection device

1312‧‧‧視覺窗口 1312‧‧‧Visual window

1320‧‧‧樣本填充部分 1320‧‧‧Sample filling part

1322‧‧‧採集位置 1322‧‧‧Collection location

1323‧‧‧觸發器 1323‧‧‧Trigger

1324,1326‧‧‧通道 1324, 1326‧‧‧channel

1325,1329‧‧‧開口 1325, 1329‧‧‧ opening

1327‧‧‧組織穿刺部件 1327‧‧‧Puncture parts

1330‧‧‧支架 1330‧‧‧Bracket

1340‧‧‧基座 1340‧‧‧Dock

1346a,1346b‧‧‧容器 1346a, 1346b‧‧‧Container

1352‧‧‧轉接通道 1352‧‧‧Transition channel

1356‧‧‧彈簧 1356‧‧‧Spring

1400‧‧‧匣 1400‧‧‧box

1410‧‧‧容器 1410‧‧‧Container

1500‧‧‧運送容器 1500‧‧‧Shipping container

1530‧‧‧採集裝置 1530‧‧‧Collection device

1540‧‧‧樣本器皿 1540‧‧‧Sample vessel

1542‧‧‧支座 1542‧‧‧support

1550‧‧‧採集裝置 1550‧‧‧Collection device

1552‧‧‧針頭 1552‧‧‧ Needle

1554‧‧‧室 Room 1554‧‧‧

1600,1602‧‧‧標識符 1600, 1602‧‧‧ identifier

1800‧‧‧樣本器皿 1800‧‧‧Sample vessel

1810‧‧‧本體 1810‧‧‧Body

1812‧‧‧頂端；脊 1812‧‧‧top; ridge

1814‧‧‧底端；脊 1814‧‧‧Bottom; ridge

1820‧‧‧蓋 1820‧‧‧cover

1830‧‧‧蓋支座 1830‧‧‧ cover support

1832‧‧‧鎖定特徵 1832‧‧‧locking features

1860‧‧‧資訊儲存單元 1860‧‧‧ Information storage unit

1910‧‧‧分隔壁；開口 1910‧‧‧Partition wall; opening

1912,1920,1922‧‧‧開口 1912, 1920, 1922

2000‧‧‧樣本採集裝置 2000‧‧‧Sample collection device

2010‧‧‧單入口路徑 2010‧‧‧Single entry path

2012‧‧‧組織穿刺部件 2012‧‧‧Organizing puncture parts

2014,2016‧‧‧單獨路徑 2014, 2016 ‧‧‧ separate path

2018,2020‧‧‧單獨容置室 2018,2020‧‧‧separate storage room

2022,2024‧‧‧轉接通道 2022, 2024‧‧‧Transition channel

2030‧‧‧樣本採集裝置 2030‧‧‧Sample collection device

2032‧‧‧單入口路徑 2032‧‧‧Single entry path

2034,2036‧‧‧單獨路徑 2034, 2036‧‧‧ separate path

2100‧‧‧採集裝置 2100‧‧‧Collection device

2102‧‧‧連接器 2102‧‧‧Connector

2104‧‧‧蝶形針頭 2104‧‧‧Butterfly needle

2106‧‧‧液體連接路徑 2106‧‧‧Liquid connection path

2108‧‧‧連接器 2108‧‧‧Connector

2160‧‧‧支座 2160‧‧‧support

2162‧‧‧防洩漏裝置 2162‧‧‧Leakproof device

2164‧‧‧第一部分 2164‧‧‧Part 1

2165‧‧‧縱軸 2165‧‧‧Vertical axis

2166‧‧‧第二部分 2166‧‧‧Part 2

2167,2168‧‧‧壁 2167, 2168‧‧‧ Wall

2170‧‧‧共同室 2170‧‧‧Common room

2172‧‧‧箭頭 2172‧‧‧arrow

2174‧‧‧空間 2174‧‧‧Space

2422‧‧‧採集通道 2422‧‧‧ Acquisition channel

2446‧‧‧容器 2446‧‧‧Container

2449‧‧‧箭頭 2449‧‧‧arrow

2454‧‧‧轉接通道 2454‧‧‧Transition channel

2455‧‧‧蓋 2455‧‧‧ cover

2500‧‧‧一體化儀器 2500‧‧‧Integrated instrument

2502‧‧‧處理器 2502‧‧‧ processor

2504‧‧‧吸量管系統 2504‧‧‧Suction pipette system

2506,2508‧‧‧箭頭 2506, 2508‧‧‧arrow

2510‧‧‧匣 2510‧‧‧Box

2512,2514,2516‧‧‧部件 2512, 2514, 2516 ‧‧‧ parts

2520‧‧‧外殼 2520‧‧‧Housing

2600‧‧‧樣本採集區域 2600‧‧‧Sample collection area

2610‧‧‧較低流動阻力區域 2610‧‧‧Lower flow resistance area

2612,2614‧‧‧通道 2612,2614‧‧‧channel

2620‧‧‧中心線 2620‧‧‧Centerline

3134‧‧‧樣本器皿 3134‧‧‧Sample vessel

3200‧‧‧運送容器 3200‧‧‧Shipping container

3210‧‧‧頂蓋 3210‧‧‧Top cover

3220‧‧‧熱調節裝置 3220‧‧‧Thermal adjustment device

3230a,3230b‧‧‧托盤；運送容器 3230a, 3230b‧‧‧pallet; shipping container

3232‧‧‧槽 3232‧‧‧slot

3234‧‧‧封閉機制 3234‧‧‧Closed mechanism

3236‧‧‧通孔 3236‧‧‧Through hole

3240‧‧‧底板 3240‧‧‧Bottom plate

3300‧‧‧運送容器 3300‧‧‧Shipping container

3302‧‧‧熱控制內部 3302‧‧‧Internal thermal control

3304‧‧‧托盤 3304‧‧‧Tray

3306‧‧‧樣本器皿 3306‧‧‧Sample vessel

3310‧‧‧支座 3310‧‧‧support

3320‧‧‧保持機制 3320‧‧‧ retention mechanism

3324‧‧‧空間 3324‧‧‧Space

3330‧‧‧開口 3330‧‧‧ opening

3400‧‧‧容器 3400‧‧‧Container

3402‧‧‧托盤 3402‧‧‧Tray

3404‧‧‧容器內部 3404‧‧‧Inside the container

3406‧‧‧器皿 3406‧‧‧ Utensils

3410‧‧‧支座 3410‧‧‧support

3420‧‧‧保持機制 3420‧‧‧ retention mechanism

3430,3432‧‧‧部件 3430,3432‧‧‧Parts

3433‧‧‧內部 3433‧‧‧Internal

3434,3436‧‧‧插塞 3434,3436‧‧‧plug

3500‧‧‧運送容器 3500‧‧‧Shipping container

3502‧‧‧蓋 3502‧‧‧ Cover

3512‧‧‧特徵 3512‧‧‧Features

3514‧‧‧空間 3514‧‧‧Space

3516‧‧‧層 3516‧‧‧ storey

3520‧‧‧保持機制 3520‧‧‧ retention mechanism

3530‧‧‧採集裝置 3530‧‧‧Collection device

3540‧‧‧樣本器皿 3540‧‧‧Sample vessel

3542‧‧‧支座 3542‧‧‧support

3550‧‧‧採集裝置 3550‧‧‧Collection device

3552‧‧‧針頭 3552‧‧‧ Needle

3554‧‧‧室 3554‧‧‧room

3570‧‧‧採集裝置 3570‧‧‧Collection device

3572‧‧‧組織穿刺部分 3572‧‧‧Puncture part

3574‧‧‧操作部分 3574‧‧‧Operation part

3576‧‧‧載體 3576‧‧‧Carrier

3578‧‧‧液體連接路徑 3578‧‧‧Liquid connection path

3600‧‧‧卸載組合 3600‧‧‧Uninstall

3602‧‧‧自動控制結構 3602‧‧‧Automatic control structure

3604,3606‧‧‧箭頭 3604,3606‧‧‧arrow

3608‧‧‧構台 3608‧‧‧Construction

3610‧‧‧可程式處理器 3610‧‧‧Programmable processor

3710,3712‧‧‧採集裝置 3710,3712‧‧‧‧collection device

3714‧‧‧內部空腔 3714‧‧‧Internal cavity

3718‧‧‧蓋 3718‧‧‧ cover

3740‧‧‧樣本採集部分 3740‧‧‧Sample collection part

3750‧‧‧轉接部分 3750‧‧‧Transfer part

3760‧‧‧樣本儲存容器 3760‧‧‧Sample storage container

3770,3782‧‧‧箭頭 3770,3782‧‧‧arrow

3780‧‧‧液體流動特徵 3780‧‧‧Liquid flow characteristics

3790,3792‧‧‧蓋 3790,3792‧‧‧cover

3800‧‧‧樣本容器 3800‧‧‧Sample container

3802,3804,3806‧‧‧匣 3802,3804,3806‧‧‧Box

4000‧‧‧運送容器 4000‧‧‧Shipping container

4010‧‧‧蓋 4010‧‧‧ Cover

4012‧‧‧檯面部分 4012‧‧‧ Countertop

4020‧‧‧凹陷 4020‧‧‧Sag

4030‧‧‧托盤 4030‧‧‧Tray

4032‧‧‧磁性或金屬部分 4032‧‧‧Magnetic or metal parts

4034‧‧‧槽 4034‧‧‧slot

4036‧‧‧凹陷 4036‧‧‧Sag

4040‧‧‧部分 4040‧‧‧

4042‧‧‧第二部分 4042‧‧‧Part II

4100‧‧‧槽 4100‧‧‧slot

4102‧‧‧托盤 4102‧‧‧Tray

B‧‧‧樣本 B‧‧‧sample

S‧‧‧對象皮膚表面 S‧‧‧ Subject's skin surface

圖式之簡單說明 Brief description of the scheme

圖1A-1B繪示依照本文所述實施例之樣本採集裝置的透視圖。 1A-1B are perspective views of a sample collection device according to embodiments described herein.

圖2A-2C繪示依照本文所述實施例之無蓋樣本採集裝置的透視圖。 2A-2C are perspective views of a sample collection device without a cover according to embodiments described herein.

圖3A-3B繪示依照本文所述實施例之樣本採集裝置的側視圖及剖視圖。 3A-3B illustrate side and cross-sectional views of a sample collection device according to embodiments described herein.

圖4A-4B繪示依照本文所述實施例之樣本採集裝置的側視圖及剖視圖。 4A-4B show side and cross-sectional views of a sample collection device according to embodiments described herein.

圖5A-5B繪示依照本文所述另一實施例之樣本採集裝置的透視圖。 5A-5B are perspective views of a sample collection device according to another embodiment described herein.

圖6A-6B繪示依照本文所述實施例之樣本採集裝置的側視圖。 6A-6B illustrate side views of sample collection devices according to embodiments described herein.

圖7A-8B繪示依照本文所述實施例之樣本採集裝置的側視圖及剖視圖。 7A-8B illustrate side and cross-sectional views of a sample collection device according to embodiments described herein.

圖9A-9C繪示依照本文所述實施例之樣本採集裝置於各使用階段之側剖視圖。 9A-9C illustrate side cross-sectional views of a sample collection device according to embodiments described herein at various stages of use.

圖10A-10B繪示依照本文所述實施例之樣本採集裝置的透視圖。 10A-10B are perspective views of a sample collection device according to embodiments described herein.

圖11A-11Z繪示依照本文所述實施例之樣本採集裝置的各種實例視圖。 11A-11Z illustrate various example views of a sample collection device according to embodiments described herein.

圖12繪示與本文所述實施例之套管頂端部分及其中相關力平衡的示意圖。 FIG. 12 is a schematic diagram showing the balance of the tip portion of the casing and the related forces in the embodiment described herein.

圖13A-13D繪示依照本文所述實施例之具有向上採集位置的各種採集裝置的視圖。 13A-13D illustrate views of various collection devices with upward collection positions according to embodiments described herein.

圖14-15繪示依照本文所述實施例之具有單個採集位置的採集裝置的各種視圖。 14-15 illustrate various views of a collection device with a single collection location according to embodiments described herein.

圖16-17繪示依照本文所述實施例之使用具有標識符之容器的樣本採集裝置的透視圖及末端視圖。 16-17 illustrate perspective and end views of a sample collection device using a container with an identifier according to embodiments described herein.

圖18A-18G繪示依照本文所述實施例之樣本容器的各種視圖。 18A-18G illustrate various views of sample containers according to embodiments described herein.

圖19A-19C繪示樣本採集裝置前端之各種實施例視圖。 19A-19C are views of various embodiments of the front end of the sample collection device.

圖20-21繪示具有一體化組織穿刺部件之樣本採集裝置的各種實施例。 20-21 illustrate various embodiments of a sample collection device with integrated tissue-piercing components.

圖22繪示依照本文所述實施例之與血液器皿穿刺器及樣本採集器同時使用之採集裝置的透視圖。 22 illustrates a perspective view of a collection device used simultaneously with a blood vessel puncture device and a sample collector according to embodiments described herein.

圖23-28繪示依照本文所述實施例之與各種樣本採集器同時使用之採集裝置的各種視圖。 23-28 illustrate various views of collection devices used simultaneously with various sample collectors according to embodiments described herein.

圖29A-29C繪示本文所述各種實施例之示意圖。 29A-29C are schematic diagrams of various embodiments described herein.

圖30-31繪示依照本文所述實施例之方法的示意圖。 30-31 are schematic diagrams of methods according to embodiments described herein.

圖32繪示本文所述系統實施例之示意圖。 32 is a schematic diagram of an embodiment of the system described herein.

圖33至37繪示本文所述採集裝置之又一實施例。 33 to 37 illustrate still another embodiment of the collection device described herein.

圖38A-39繪示依照本文所述至少一個實施例之熱控制樣本器皿運送裝置的各種視圖。 38A-39 illustrate various views of a thermally controlled sample vessel transport device in accordance with at least one embodiment described herein.

圖40A-40C繪示本文所述各種實施例之示意圖。 40A-40C are schematic diagrams of various embodiments described herein.

圖41繪示依照本文所述至少一個實施例之其中具有複數個樣本器皿的樣本運送容器一部分之透視圖。 41 illustrates a perspective view of a portion of a sample transport container having a plurality of sample vessels in accordance with at least one embodiment described herein.

圖42繪示依照本文所述至少一個實施例之其中具有複數個樣本器皿的樣本運送容器一部分之分解透視圖。 42 illustrates an exploded perspective view of a portion of a sample transport container having a plurality of sample vessels in accordance with at least one embodiment described herein.

圖43繪示依照本文所述另一實施例之樣本運送容器的透視圖。 43 is a perspective view of a sample transport container according to another embodiment described herein.

圖44繪示依照本文所述實施例之樣本採集及運送程序的示意圖。 FIG. 44 is a schematic diagram of a sample collection and delivery procedure according to the embodiments described herein.

圖45繪示依照本文所述又一實施例之樣本採集及運送程序的示意圖。 45 is a schematic diagram of a sample collection and delivery procedure according to yet another embodiment described herein.

圖46繪示依照本文所述實施例之樣本採集裝置。 FIG. 46 illustrates a sample collection device according to embodiments described herein.

圖47繪示依照本文所述實施例之用於將樣本器皿自運送容器卸載之系統的示意圖。 47 shows a schematic diagram of a system for unloading sample vessels from a shipping container according to embodiments described herein.

圖48為顯示本文所提供之器皿中樣本所含分析物的穩定性圖形。 Figure 48 is a graph showing the stability of the analyte contained in the sample in the vessel provided herein.

圖49至51繪示依照本文所述至少一個實施例之測試的非限制性實例。 Figures 49 to 51 show non-limiting examples of tests in accordance with at least one embodiment described herein.

圖52至55繪示依照本文所述實施例之裝置及系統的各種視圖。 52 to 55 show various views of devices and systems according to embodiments described herein.

圖56至59繪示依照本文所述實施例之樣本運送裝置的各種視圖。 56 to 59 illustrate various views of a sample transport device according to embodiments described herein.

具體實施方式 detailed description

應暸解，上述一般說明及下文詳細說明僅為示例性及解釋性，而不是用以限定本發明。值得注意的是，本發明說明及後附申請專利範圍中所用之單數形式“一”、“一個”及“所述”亦包括相應複數形式，上下文中明確另行指定者除外。因此，例如“一種材料”亦可包括多種材料之混合，“一種複合物”亦可包括多種複合物等等。本文所引用之參考經由引用被整體結合入本文中，與本發明說明中明確闡述之教示抵觸者除外。 It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and are not intended to limit the present invention. It is worth noting that the singular forms "a", "an" and "said" used in the description of the present invention and the appended patent applications also include the corresponding plural forms, unless the context clearly specifies otherwise. Thus, for example, "a material" may also include a mixture of multiple materials, "a composite" may also include multiple composites, and so on. The references cited herein are incorporated by reference in their entirety, except for those that contradict the teachings explicitly set forth in the description of the invention.

於本發明說明及其後之申請專利範圍中，將使用定義具有以下含義之數個術語： “可選”或“可選地”係指其隨後說明之情形可能或可能不發生，如此該說明係包括該情形發生之實例，亦包括該情形不發生之實例。舉例而言，如某一裝置可選地包含樣本採集孔之特徵，則意指此樣本採集孔可能或可能不存在，因而此說明包括兩種結構，即其中裝置擁有此樣本採集孔之結構及其中此樣本採集孔不存在之結構。 In the description of the invention and subsequent patent applications, several terms with the following meanings will be used: "Optional" or "optionally" means that the situation that it subsequently explains may or may not occur, so the description includes both instances where the situation occurs and also instances where the situation does not occur. For example, if a device optionally includes the feature of a sample collection hole, it means that the sample collection hole may or may not exist, so this description includes two structures, namely, a structure in which the device has the sample collection hole The structure in which this sample collection hole does not exist.

如本文中所用，術語“大幅度的/相當大程度的”係指超過最小或少量數目；“大幅度地/相當大程度地”係指超過最低限度地或微不足道地。因此，例如本文所用之短語“大幅度地/相當大程度地不同”表示兩個數值之間充分大之差異程度，以致熟習此技藝者將會認為該兩個數值之間的差異於籍由該等數值衡量之特徵上下文中具有統計顯著性。因此，彼此大幅地不同之兩個數值之間的差異作為參考數值或比較數值之函數，通常大於約10%，且可能大於約20%，優選地大於約30%，優選地大於約40%，優選地大於約50%。 As used herein, the term "large / substantial" refers to exceeding a minimum or a small number; "substantially / substantially" refers to exceeding a minimum or insignificant. Therefore, for example, the phrase "largely / substantially different" as used herein means a sufficiently large difference between two values, so that those skilled in the art will think that the difference between the two values is due to The characteristics of these numerical measurements are statistically significant in the context. Therefore, the difference between two values that are substantially different from each other as a function of a reference value or a comparison value is usually greater than about 10%, and may be greater than about 20%, preferably greater than about 30%, preferably greater than about 40%, Preferably greater than about 50%.

如本文中所用，“樣本”可為但不限於血樣或血樣之一部分，可為任何合適容量或體積，且優選地具有小容量或體積。於本文所披露之分析及方法的一些實施例中，可使用小體積血樣或血樣之不超過小體積部分進行測量，其中小體積為不超過約5mL；或為不超過約3mL；或為不超過約2mL；或為不超過約1mL；或為不超過約500μL；或為不超過約250μL；或為不超過約100μL；或為不超過約75μL；或為不超過約50μL；或為不超過 約35μL；或為不超過約25μL；或為不超過約20μL；或為不超過約15μL；或為不超過約10μL；或為不超過約8μL；或為不超過約6μL；或為不超過約5μL；或為不超過約4μL；或為不超過約3μL；或為不超過約2μL；或為不超過約1μL；或為不超過約0.8μL；或為不超過約0.5μL；或為不超過約0.3μL；或為不超過約0.2μL；或為不超過約0.1μL；或為不超過約0.05μL；或為不超過約0.01μL。 As used herein, a "sample" may be, but is not limited to, a blood sample or a portion of a blood sample, may be of any suitable volume or volume, and preferably has a small volume or volume. In some embodiments of the analysis and methods disclosed herein, a small volume of blood sample or a portion of the blood sample that does not exceed the small volume can be used for measurement, where the small volume is not more than about 5 mL; or is not more than about 3 mL; or is not more than About 2mL; or not more than about 1mL; or not more than about 500μL; or not more than about 250μL; or not more than about 100μL; or not more than about 75μL; or not more than about 50μL; or not more than About 35 μL; or not more than about 25 μL; or not more than about 20 μL; or not more than about 15 μL; or not more than about 10 μL; or not more than about 8 μL; or not more than about 6 μL; or not more than about 5μL; or not more than about 4μL; or not more than about 3μL; or not more than about 2μL; or not more than about 1μL; or not more than about 0.8μL; or not more than about 0.5μL; or not more than About 0.3 μL; or not more than about 0.2 μL; or not more than about 0.1 μL; or not more than about 0.05 μL; or not more than about 0.01 μL.

如本文中所用，術語“服務點位置”可包括對象可接收服務(如測試、監測、治療、診斷、指導、樣本採集、ID驗證、醫療服務、非醫療服務等)之位置，且可包括但不限於對象的家、對象的公司、保健業者(如醫師)位置、醫院、急診室、手術室、診所、保健業者辦公室、實驗室、零售商[如藥房(如零售藥房、診所藥房、醫院藥房)、藥店、超級市場、雜貨店等]、運輸車輛(如汽車、船舶、卡車、公共汽車、飛機、機車、救護車、移動單位、消防車、緊急車輛、執法車輛、警車或其它適於將對象從一點運送至另一點之車輛等)、移動醫療護理單位、移動單位、學校、日間護理中心、安全篩選場所、戰鬥場所、保健輔助式照護住所、政府辦公室、辦公樓、帳篷、體液樣本獲取場所(如血液採集中心)、對象意欲進入之場所的入口或鄰近位置、對象意欲使用之裝置的位置或鄰近位置(舉例而言，如對象意欲使用電腦，則該電腦的位置)、樣本處理裝置接收樣本之位置，或本文中其它 部分所述任何其它服務點位置。 As used herein, the term "service point location" may include the location where a subject can receive services (such as testing, monitoring, treatment, diagnosis, guidance, sample collection, ID verification, medical services, non-medical services, etc.), and may include but Not limited to subject's home, subject's company, health care provider (such as physician) location, hospital, emergency room, operating room, clinic, health provider's office, laboratory, retailer [such as pharmacy (such as retail pharmacy, clinic pharmacy, hospital pharmacy ), Pharmacies, supermarkets, grocery stores, etc.), transportation vehicles (such as cars, ships, trucks, buses, airplanes, locomotives, ambulances, mobile units, fire trucks, emergency vehicles, law enforcement vehicles, police vehicles or other suitable vehicles Subjects are transported from one point to another, etc.), mobile medical care units, mobile units, schools, day care centers, safety screening sites, battle places, health care assisted care shelters, government offices, office buildings, tents, body fluid samples Location (eg blood collection center), entrance or proximity to the location where the subject intends to enter, location or proximity of the device the subject intends to use (for example, the location of the computer if the subject intends to use a computer), sample processing device The location where the sample was received, or other in this article Any other service point locations described in the section.

如本文中所用，“體液樣本採集器”或任何其它採集機制可為一次性的。舉例而言，某一體液採集器可使用一次即被丟棄。體液採集器可具有一個或多個一次性部件。或者，體液採集器可為再度使用的。該體液採集器可被再度使用任意多次。於一些實例中，體液採集器可同時包括可再度使用及一次性部件。 As used herein, a "body fluid sample collector" or any other collection mechanism may be disposable. For example, a body fluid collector can be used once and then discarded. The body fluid collector may have one or more disposable components. Alternatively, the body fluid collector can be reused. The body fluid collector can be reused any number of times. In some examples, the body fluid collector may include both reusable and disposable components.

如本文中所用，“樣本採集單位”和/或所述裝置之任意其它部分能夠接收單種樣本類型或多種樣本類型。舉例而言，樣本採集單位能夠接收兩種不同體液類型(如血液、眼淚)。於另一實例中，樣本採集單位能夠接收兩種不同生物樣本類型(如尿樣、糞便樣本)。多種樣本類型可為或不為液體、固體和/或半固體。舉例而言，樣本採集單位能夠接收體液、分泌物和/或組織樣本中一種或更多種、兩種或更多種，或三種或更多種。 As used herein, a “sample collection unit” and / or any other part of the device can receive a single sample type or multiple sample types. For example, a sample collection unit can receive two different body fluid types (eg blood, tears). In another example, the sample collection unit can receive two different types of biological samples (such as urine samples and stool samples). The various sample types may or may not be liquid, solid, and / or semi-solid. For example, the sample collection unit can receive one or more, two or more, or three or more of the body fluids, secretions, and / or tissue samples.

如本文中所用，“非吸收、未添加基質形式”係指液體或混懸液未被吸收或抽入邊帶、網狀物、纖維墊、吸收性材料、吸收性結構、纖維濾網等等，其改變液體或混懸液形態，或將樣本成分限於其中，以致液態樣本之完整性被改變，無法在保證樣本分析所需之樣本完整性的同時，以液體形態取出樣本。 As used herein, "non-absorbed, unadded matrix form" means that the liquid or suspension is not absorbed or drawn into sidebands, meshes, fiber mats, absorbent materials, absorbent structures, fiber filters, etc. It changes the shape of the liquid or suspension, or limits the sample composition, so that the integrity of the liquid sample is changed, and the sample cannot be taken out in liquid form while ensuring the sample integrity required for sample analysis.

如本文中所用，術語“樣本處置系統”係指被配置為有助於樣本成像、檢測、定位、重定位、停留、提取及沉積之裝置或系統。於另一實例中，可能或可能不具 有(其它)自動功能之吸量管即為樣本處置系統。籍由樣本處置系統處置之樣本可能或可能不包括液體。取樣處置系統能夠運送體液、分泌物和/或組織。取樣處置系統能夠運送裝置中不一定為樣本之一種或多種物質。舉例而言，樣本處置系統能夠運送可與一件或多件樣本反應之粉末。於某些情況下，樣本處置系統為液體處置系統。該液體處置系統可包括各種類型之泵及閥門或吸量管，其可包括但不限於正排量式吸量管、空氣排量式吸量管及吸入式吸量管。樣本處置系統可借助本文其它部分所述之機器人運送樣本或其他物質。 As used herein, the term "sample handling system" refers to a device or system configured to facilitate sample imaging, detection, positioning, repositioning, dwelling, extraction, and deposition. In another example, it may or may not have The pipette with (other) automatic function is the sample disposal system. Samples handled by the sample disposal system may or may not include liquids. The sampling treatment system can transport body fluids, secretions and / or tissues. The sampling and disposal system can transport one or more substances that are not necessarily samples in the device. For example, a sample handling system can transport powder that can react with one or more samples. In some cases, the sample disposal system is a liquid disposal system. The liquid treatment system may include various types of pumps and valves or pipettes, which may include, but are not limited to, positive displacement pipettes, air displacement pipettes, and suction pipettes. The sample disposal system can transport samples or other substances with the help of robots described elsewhere in this article.

如本文中所用，術語“保健業者”係指向對象提供醫療和/或醫學建議之醫師或其他保健專業人士。保健專業人士可包括與保健系統相關之個人或實體。保健專業人士實例可包括醫師(包括全科醫師及專科醫師)、外科醫師、牙醫師、聽力治療師、言語病理學家、醫師助理、護士、助產士、藥學家/藥劑師、營養專家、治療師、心理學家、脊骨神經醫師、診所職員、物理治療師、刺絡醫師、職業治療師、驗光師、急診技術員、護理人員、醫學實驗室技術員、醫學修復技術員、放射線技師、社會工作者及各種經培訓提供某種類型保健服務之其它人力資源。保健專業人士可能或可能不具有資格書寫處方。保健專業人士可工作或附屬於醫院、保健點及其它服務提供點，或還可從事學術培訓、研究及管理。某些保健專業人士可於私人或公立住所、社區中心或聚集地或移動單位 向病患提供護理及治療服務。社區保健工作者可於正規保健機構之外工作。保健服務經理、醫學記錄及保健資訊技術員及其他支持工作者亦可為醫療專業人士或附屬於保健業者。保健專業人士可為向個人、家庭或社區提供預防、治療、增進或復原保健服務之個人或機構。 As used herein, the term "healthcare provider" refers to a physician or other healthcare professional who provides medical and / or medical advice to the subject. Health professionals may include individuals or entities related to the health care system. Examples of healthcare professionals may include physicians (including general practitioners and specialists), surgeons, dentists, audiotherapists, speech pathologists, physician assistants, nurses, midwives, pharmacists / pharmacists, nutrition experts, therapists , Psychologists, spinal neurologists, clinic staff, physical therapists, piercing physicians, occupational therapists, optometrists, emergency technicians, nursing staff, medical laboratory technicians, medical repair technicians, radiological technicians, social workers and Various other human resources trained to provide certain types of health services. Health professionals may or may not be eligible to write prescriptions. Health professionals can work or be affiliated with hospitals, health centers, and other service providers, or they can engage in academic training, research, and management. Certain health care professionals can be in private or public residences, community centers or gathering places or mobile units Provide nursing and treatment services to patients. Community health workers can work outside of regular health institutions. Health service managers, medical records and health information technicians and other support workers may also be medical professionals or affiliated with the health care industry. A health care professional may be an individual or institution that provides preventive, therapeutic, promotion or rehabilitation health care services to individuals, families or communities.

於一些實施例中，保健專業人士可早已熟悉對象或已與對象交流過。對象可為該保健專業人士之病患。於一些實例中，該保健專業人士可已開處方要求對象作臨床測試。該保健專業人士可已指示或建議對象於服務點或實驗室作臨床測試。於一個實例中，該保健專業人士可為該對象之初級照護醫師。該保健專業人士可為該對象之任意類型醫師(包括可選地通過遠程醫療服務選擇或聯繫之全科醫師、轉診醫師或病患自己的醫師，和/或專科醫師)。該保健專業人士可為醫護專業人士。 In some embodiments, the healthcare professional may already be familiar with or have communicated with the subject. The target may be the patient of the health care professional. In some instances, the health care professional may have prescribed a subject to be tested clinically. The health care professional may have instructed or recommended the subject to perform a clinical test at a service point or laboratory. In one example, the health care professional may be the primary care physician for the subject. The health care professional may be any type of physician of the subject (including general practitioners, referral physicians or patient's own physicians, and / or specialist physicians who are optionally selected or contacted via telemedicine services). The healthcare professional may be a healthcare professional.

如本文中所用，術語“架”係指用於安裝多個模塊之框架或外殼。該架被配置為允許模塊被固定至架上或與其結合。於一些情形中，該架之各種尺寸可被規範化。於一個實例中，模塊間隔被規範為至少約0.5英寸、或1英寸、或2英寸、或3英寸、或4英寸、或5英寸、或6英寸、或7英寸、或8英寸、或9英寸、或10英寸、或11英寸、或12英寸之倍數。 As used herein, the term "rack" refers to a frame or enclosure for mounting multiple modules. The rack is configured to allow the module to be fixed to or combined with the rack. In some cases, various sizes of the rack can be standardized. In one example, the module spacing is specified to be at least about 0.5 inches, or 1 inch, or 2 inches, or 3 inches, or 4 inches, or 5 inches, or 6 inches, or 7 inches, or 8 inches, or 9 inches , Or multiples of 10 inches, or 11 inches, or 12 inches.

生物樣本上下文中所用之術語“細胞”涵蓋通常具有與單個細胞相似尺寸之樣本，包括但不限於小囊(如脂質體)、細胞、病毒體及約束於諸如微珠、納米顆 粒或微球等小顆粒上之物質。特徵包括但不限於尺寸；形狀；細胞移動或增殖等時間及動態變化；粒度；細胞膜是否完整；內部細胞內容，包括但不限於蛋白質內容、蛋白質改性、核酸內容、核酸改性、細胞器官內容、細胞核結構、細胞核內容、內部細胞結構、內部囊內容、鐵濃度及類固醇或藥物等其他小分子之存在；及細胞表面(細胞膜及細胞壁)標記，包括蛋白質、脂質、碳水化合物及其改造。 The term "cell" as used in the context of biological samples encompasses samples that generally have a similar size to a single cell, including but not limited to small vesicles (such as liposomes), cells, virions and confined to such as microbeads, nanoparticle Substances on small particles such as granules or microspheres. Features include but are not limited to size; shape; time and dynamic changes such as cell movement or proliferation; particle size; cell membrane integrity; internal cell content, including but not limited to protein content, protein modification, nucleic acid content, nucleic acid modification, cell organ content , Nuclear structure, nuclear content, internal cell structure, internal capsule content, iron concentration, and the presence of other small molecules such as steroids or drugs; and cell surface (cell membrane and cell wall) markers, including proteins, lipids, carbohydrates and their transformation

如本文中所用，術語“樣本”係指整個原樣本或其任意部分，上下文明確另行指示者除外。 As used herein, the term "sample" refers to the entire original sample or any portion thereof, unless the context clearly indicates otherwise.

本發明提供用於樣本或健康參數之多用途分析的系統和方法。可於一個裝置上採集樣本，並完成一個或多個樣本準備步驟、分析步驟和/或檢測步驟。本文所述本發明之各方面可被應用於任意下述特定應用、系統和裝置。本發明可作為獨立系統或方法應用，或可作為一體化系統之一部分應用，如於包括定點保健服務之系統中。於一些實施例中，該系統可包括外部成像技術，如超聲或MRI或與外部週邊設備整合以進行一體化成像，及其他保健測試或服務。應暸解，本發明之不同方面可個別地、共同地或彼此組合地加以理解及運用。 The present invention provides systems and methods for multi-purpose analysis of samples or health parameters. Samples can be collected on one device, and one or more sample preparation steps, analysis steps, and / or detection steps can be completed. The aspects of the invention described herein can be applied to any of the specific applications, systems, and devices described below. The present invention can be applied as an independent system or method, or can be applied as part of an integrated system, such as in a system that includes designated health care services. In some embodiments, the system may include external imaging technology, such as ultrasound or MRI, or integrated with external peripheral devices for integrated imaging, and other health care tests or services. It should be understood that different aspects of the present invention can be understood and applied individually, collectively, or in combination with each other.

現請參考圖1A-1B，現將說明樣本採集裝置100之實施例。於此非限制性實例中，該樣本採集裝置100可包括採集裝置本體120、支架130及基座140。於一些實例中，可選地提供有蓋110。於一個實施例中，該蓋 可被用於保護開口、使其保持清潔，並於採集後蓋住有血之尖端。可選地或另外地，該蓋亦可被用於籍由控制提供給毛細管之排氣量，於將樣本液體轉移入樣本容器之過程中限制流量。一些實施例可於該蓋中包括排氣路徑(永久開放或可***作地可關閉)，而其它實施例則不包括。可選地，該採集裝置本體120可包括裝置100之第一部分，具有能夠接收樣本B之一條或多條採集路徑，諸如但不限於其中之採集通道122a及122b。圖1A繪示樣本B僅部分地填充通道122a及122b，但應暸解，儘管一些替代實施例中未排除部分填充，於多數實施例中，當填充過程完成後，該等通道將被樣本B全部填滿。於此實施例中，基座140可具有一個或多個指示器142a及142b，諸如但不限於光學指示器，它們可提供有關樣本是否到達基座上所放置之一個或多個容器的指示。應暸解，儘管此指示可為視覺指示，諸如聲音、震動或其它指示方式之其它指示方式可取代此指示方式或與其組合使用。指示器可位於所述容器中至少一個之上。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 Referring now to FIGS. 1A-1B, an embodiment of the sample collection device 100 will now be described. In this non-limiting example, the sample collection device 100 may include a collection device body 120, a stand 130, and a base 140. In some examples, a cover 110 is optionally provided. In one embodiment, the cover It can be used to protect the opening, keep it clean, and cover the bloody tip after collection. Alternatively or additionally, the cap can also be used to restrict the flow rate during the transfer of the sample liquid into the sample container by controlling the amount of exhaust gas provided to the capillary. Some embodiments may include an exhaust path (permanently open or operably closeable) in the cover, while other embodiments do not. Optionally, the collection device body 120 may include the first part of the device 100, having one or more collection paths capable of receiving the sample B, such as but not limited to the collection channels 122a and 122b therein. FIG. 1A shows that sample B only partially fills channels 122a and 122b, but it should be understood that although some alternative embodiments do not exclude partial filling, in most embodiments, when the filling process is completed, the channels will be completely filled by sample B Fill up. In this embodiment, the base 140 may have one or more indicators 142a and 142b, such as but not limited to optical indicators, which may provide an indication as to whether the sample has reached one or more containers placed on the base. It should be understood that although this indication may be a visual indication, other indications such as sound, vibration, or other indications may replace or be used in combination with this indication. The indicator may be located on at least one of the containers. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

儘管為方便繪示起見未示出，支架130亦可包括一個或多個顯示通道122a及122b中是否達到所需填充程度之填充指示器。這可取代或另加於填充指示器142a及142b。當然，該一個或多個路徑填充指示器可被置於不同部分，且不僅限於支架130上。應暸解，儘管此通道122a及122b中一個或多個之填充程度指示可為視覺指示，諸如 聲音、震動或其它指示方式之其它指示方式可取代此指示方式或與其組合使用。指示器可位於採集路徑中至少一個之上。可選地，指示器位於所有採集路徑中。 Although not shown for ease of illustration, the bracket 130 may also include one or more display channels 122a and 122b to indicate whether a desired filling level is reached. This can replace or add to the fill indicators 142a and 142b. Of course, the one or more path filling indicators may be placed in different parts, and not limited to the bracket 130. It should be understood that although the filling level indication of one or more of the channels 122a and 122b may be a visual indication, such as Other indication methods such as sound, vibration or other indication methods can replace this indication method or be used in combination with it. The indicator may be located on at least one of the acquisition paths. Optionally, the indicator is located in all acquisition paths.

於本實施例中，支架130可被用於與本體120及基座140結合，形成一體化裝置。應暸解，儘管裝置本體120、支架130及基座140被敘述為單獨部件，這些部件中一個或多個可整體形成，以簡化製造，且本文中不排除此類整合。 In this embodiment, the bracket 130 can be used to combine with the body 120 and the base 140 to form an integrated device. It should be understood that although the device body 120, the bracket 130, and the base 140 are described as separate components, one or more of these components may be integrally formed to simplify manufacturing, and such integration is not excluded herein.

於本文所述一些實施例中，可選地提供有蓋110。於一個非限制性實例中，該蓋可被罩於採集裝置本體120之一部分上。該蓋110係可從採集裝置本體120上分離。於一些實例中，該蓋110係可完全地從採集裝置本體120上分離，或可保留與該採集裝置本體相連之一部分，諸如但不限於籍由鉸接或其他方式與採集裝置相連。該蓋110可覆蓋採集裝置本體120之一部分，包括其中一個或多個通道之暴露末端。該蓋110當其就位時，可防止如空氣、液體或顆粒等材料進入裝置本體中的通道。可選地，可使用任意已知或今後於本領域中開發之技術將該蓋110附於採集本體120上。舉例而言，該蓋可為按扣配合、擰上、摩擦配合、夾合、帶磁性部分、捆綁、使用彈性部分和/或與該採集裝置本體可移除地相連。該蓋可與該採集裝置本體形成防液體密封。該蓋可由不透明、透明或半透明材料製成。 In some embodiments described herein, a cover 110 is optionally provided. In a non-limiting example, the cover may be covered on a part of the collection device body 120. The cover 110 can be separated from the main body 120 of the collection device. In some examples, the cover 110 may be completely detached from the collection device body 120, or may retain a part connected to the collection device body, such as but not limited to be connected to the collection device by hinge or other means. The cover 110 may cover a part of the collection device body 120, including the exposed end of one or more channels. When the cover 110 is in place, it can prevent materials such as air, liquid, or particles from entering the channel in the device body. Alternatively, the cover 110 can be attached to the collection body 120 using any technique known or later developed in the art. For example, the cover may be a snap fit, screw on, friction fit, clip, magnetic part, binding, use of an elastic part, and / or be removably connected to the body of the collection device. The cover can form a liquid-proof seal with the collection device body. The cover may be made of opaque, transparent or translucent material.

於一個實施例中，樣本採集裝置之採集裝置本 體120可包含諸如但不限於其中之採集通道122a及122b之一條或多條採集路徑的一部分。應暸解，並未排除不是通道形式之採集路徑。採集裝置本體可與可包含其中一條或多條通道之一部分的支架130連接。採集裝置本體可永久性地附於該支架上，或相對於該支架為可移去。於一些實例中，該採集裝置本體及該支架可形成一單個整體。或者，該採集裝置本體及該支架可從單獨部件形成。於該裝置運行過程中，該採集裝置與該支架彼此不相互移動。 In one embodiment, the collection device of the sample collection device The body 120 may include a portion of one or more acquisition paths such as, but not limited to, acquisition channels 122a and 122b therein. It should be understood that acquisition paths that are not in the form of channels are not excluded. The body of the collection device may be connected to a bracket 130 that may include a portion of one or more channels. The body of the collection device can be permanently attached to the stand or removable relative to the stand. In some examples, the collection device body and the support may form a single unit. Alternatively, the collection device body and the bracket may be formed from separate components. During the operation of the device, the collection device and the support do not move with each other.

可選地，採集裝置本體120可由一種光透射材料整體或部分製成。舉例而言，此採集裝置本體可由一種透明或半透明材料製成。可選地，該本體僅有特選部分為透明或半透明，以使液體採集通道為可視。可選地，該本體為一種不透明材料，惟其中可形成有開口和/或窗口以顯示其中填充程度。此採集裝置本體可使使用者能夠觀看此裝置本體中和/或貫穿此裝置本體之通道122a及122b。該通道可由一種透明或半透明材料製成，可允許使用者觀察樣本B是否已通過該通道。該通道可具有相當大程度相等之長度。於一些實例中，支架130可由一種不透明材料、一種透明材料或一種半透明材料製成。該支架可能或可能不具有與採集裝置本體相同之光學特徵。該支架可由一種與採集裝置本體不同之材料或一種與採集裝置本體相同之材料製成。 Alternatively, the collection device body 120 may be made entirely or partially of a light-transmitting material. For example, the body of the collection device can be made of a transparent or translucent material. Optionally, only selected parts of the body are transparent or translucent, so that the liquid collection channel is visible. Optionally, the body is an opaque material, but an opening and / or window may be formed therein to show the degree of filling therein. The collection device body enables the user to view the channels 122a and 122b in and / or through the device body. The channel may be made of a transparent or translucent material, which allows the user to observe whether the sample B has passed through the channel. The channel can have a considerable degree of equal length. In some examples, the bracket 130 may be made of an opaque material, a transparent material, or a translucent material. The holder may or may not have the same optical characteristics as the body of the collection device. The bracket can be made of a material different from the body of the collection device or a material the same as the body of the collection device.

採集裝置本體120可為任意形狀或尺寸。於一些實例中，採集裝置本體可為圓形、橢圓形、三角形、四 邊形(如正方形、長方形、梯形)、五邊形、六邊形、八邊形或任意其它剖面形狀。此剖面形狀沿採集裝置本體長度可保持不變或可變化。於一些實例中，採集裝置本體可具有小於或等於約10cm²、7cm²、5cm²、4cm²、3cm²、2.5cm²、2cm²、1.5cm²、1cm²、0.8cm²、0.5cm²、0.3cm²或0.1cm²之剖面面積。此剖面面積沿採集裝置本體120之長度可保持不變或可變化。該採集裝置本體可具有小於或等於約20cm、15cm、12cm、10cm、9cm、8cm、7cm、6cm、5cm、4cm、3cm、2cm、1cm、0.5cm或0.1cm之長度。該採集裝置本體120可具有比蓋、支架或基座更大或更小之長度，或具有與蓋、支架或基座相等之長度。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 The collection device body 120 can be of any shape or size. In some examples, the collection device body may be circular, elliptical, triangular, quadrangular (such as square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. The cross-sectional shape can be kept constant or variable along the length of the collecting device body. In some examples, the collection device body may have less than or equal to about 10 cm ² , 7 cm ² , 5 cm ² , 4 cm ² , 3 cm ² , 2.5 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ² , 0.8 cm ² , 0.5 cm ² , 0.3cm ² or 0.1cm ² cross-sectional area. The cross-sectional area can be kept constant or variable along the length of the collection device body 120. The body of the collection device may have a length less than or equal to about 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or 0.1 cm. The collection device body 120 may have a larger or smaller length than the cover, bracket, or base, or have the same length as the cover, bracket, or base. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

於一個實施例中，諸如但不限於通道122a及122b等採集路徑亦可具有某一選定剖面形狀。通道之一些實施例沿通道整個長度可具有相同之剖面形狀。可選地，此剖面形狀沿長度可保持不變或可變化。舉例而言，一些實施例可於某一位置具有一種形狀，而於沿通道長度之一個或更多個不同位置具有一種不同之形狀。一些實施例可具有為一種剖面形狀之一條通道及為一種不同剖面形狀之至少一條其它通道。作為非限制性實例，一些實施例可具有圓形、橢圓形、三角形、四邊形(如正方形、長方形、梯形)、五邊形、六邊形、八邊形或任意其它剖面形狀。本體、支架及基座可為相同之剖面形狀，或可為不同。一 些實施例可選擇形狀，使可被容置於通道中的液體體積對於特定通道寬度和/或高度最大化。一些實施例可具有通道122a及122b之一有一種剖面形狀，而另一通道有一種不同的剖面形狀。於一個實施例中，通道之剖面形狀可有助於最大化其中體積，惟可選地，其亦可最優化施加於血液上之毛細吸力。這將實現最大化之填充率。應暸解，於一些實施例中，通道之剖面形狀可直接影響毛細管力。作為非限制性實例，一定體積樣本可被容納於一條淺但寬之通道中，或者一條圓形通道中，兩者皆容納相同體積，惟因填充速度、夾雜空氣之較低可能性或與通道性能相關之因素，其中之一優選於另一者。 In one embodiment, acquisition paths such as but not limited to channels 122a and 122b may also have a selected cross-sectional shape. Some embodiments of the channel may have the same cross-sectional shape along the entire length of the channel. Optionally, this cross-sectional shape may remain constant or variable along the length. For example, some embodiments may have a shape at a certain location and a different shape at one or more different locations along the length of the channel. Some embodiments may have one channel with a cross-sectional shape and at least one other channel with a different cross-sectional shape. As a non-limiting example, some embodiments may have a circular shape, an elliptical shape, a triangular shape, a quadrangular shape (eg, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. The body, bracket and base may be the same cross-sectional shape, or may be different. One Some embodiments may select shapes to maximize the volume of liquid that can be contained in the channel for a specific channel width and / or height. Some embodiments may have one of the channels 122a and 122b having a cross-sectional shape, while the other channel has a different cross-sectional shape. In one embodiment, the cross-sectional shape of the channel can help maximize its volume, but optionally, it can also optimize the capillary suction applied to the blood. This will maximize the fill rate. It should be understood that in some embodiments, the cross-sectional shape of the channel can directly affect the capillary force. As a non-limiting example, a sample of a certain volume may be contained in a shallow but wide channel, or a circular channel, both of which contain the same volume, but due to the filling speed, the lower possibility of entrained air One of the factors related to performance is preferred to the other.

儘管通道可具有任意形狀或尺寸，一些實施例配置為使得通道與樣本液體接觸之時展示毛細管作用。於一些實例中，通道可具有小於或等於約10mm²、7mm²、5mm²、4mm²、3mm²、2.5mm²、2mm²、1.5mm²、1mm²、0.8mm²、0.5mm²、0.3mm²或0.1mm²之剖面面積。此剖面尺寸沿長度可保持不變或可變化。一些實施例可沿特定長度定制用於較大力，隨後於另一長度中用於較小的力。此剖面形狀沿長度可保持不變或可變化。一些通道配置為直通道。一些實施例可僅具有或與直部分組合具有彎曲或其它形狀之路徑形狀。一些於裝置本體120中可具有不同之方位。舉例而言，當裝置被相當大程度水平地持著時，一條或多條通道於輸送液體離開裝置上之最初採集點時，可向下傾斜、向上傾斜，或完全不傾 斜。 Although the channels can have any shape or size, some embodiments are configured such that the channels exhibit capillary action when in contact with the sample liquid. In some examples, the channel may have less than or equal to about 10 mm ² , 7 mm ² , 5 mm ² , 4 mm ² , 3 mm ² , 2.5 mm ² , 2 mm ² , 1.5 mm ² , 1 mm ² , 0.8 mm ² , 0.5 mm ² , 0.3 mm ² or 0.1mm ² cross-sectional area. The cross-sectional dimension can be kept constant or variable along the length. Some embodiments can be customized for a larger force along a specific length and then used for a smaller force in another length. The cross-sectional shape can be kept constant or variable along the length. Some channels are configured as straight channels. Some embodiments may only have a curved or other shaped path shape in combination with the straight portion. Some may have different orientations in the device body 120. For example, when the device is held horizontally to a considerable degree, one or more channels may be tilted downward, tilted upward, or not tilted at all when the transport liquid leaves the initial collection point on the device.

通道122a及122b可籍由裝置本體120和/或支架130支持。於一些實例中，通道之整長可被包含於裝置本體與支架之組合中。於一些實例中，通道之一部分可處於裝置本體中，而通道之一部分可處於支架中。通道之位置可籍由裝置本體和/或支架固定。於一些實施例中，通道可被限定為中空針頭中的內腔。於一些實施例中，通道僅於三邊被限定，至少一邊為開放式。可選地，與本體分離之蓋層可限定否則為開放之邊。一些實施例可採用不同材料限定通道之不同邊。這些材料均可由本體提供，或它們可由採集裝置之不同部件提供。一些實施例可使所有通道位於同一平面上。可選地，一些實施例可具有一種形狀，使所述通道至少一部分位於不同平面和/或方位。可選地，一些通道可完全位於一個不同平面和/或方位。 The channels 122a and 122b may be supported by the device body 120 and / or the bracket 130. In some examples, the entire length of the channel may be included in the combination of the device body and the stand. In some examples, a portion of the channel may be in the device body, and a portion of the channel may be in the bracket. The position of the channel can be fixed by the device body and / or the bracket. In some embodiments, the channel may be defined as a lumen in the hollow needle. In some embodiments, the channel is limited only on three sides, and at least one side is open. Alternatively, the cover layer separated from the body may define an otherwise open side. Some embodiments may use different materials to define different sides of the channel. These materials can all be provided by the body, or they can be provided by different parts of the collection device. Some embodiments may place all channels on the same plane. Alternatively, some embodiments may have a shape such that at least a portion of the channels are located in different planes and / or orientations. Alternatively, some channels may be located completely in a different plane and / or orientation.

於一些實例中，可提供有複數條通道。於一些實施例中，一條通道***為兩條或更多條通道。可選地，一些通道***為甚至更多數目之通道。一些通道可包括諸如但不限於導引通道中流動之閥門等控制機制。所述通道至少一部分可彼此為相當大程度地平行。或者，無通道部分需要彼此平行。於一些實例中，所述通道至少一部分彼此不平行。可選地，可輕微彎曲所述通道。可選地，通道可於某一位置具有一種剖面面積，而在沿通道之不同位置具有較小的剖面面積。可選地，通道可於某一位置具有一種剖面面積，而在沿通道之不同位置具有較大的剖面面 積。對於Y設計之一些實施例，通道宜具有合適放置之排氣口，以便為各小瓶限定樣本，由此使得不會從其它通道抽取樣本或出現交叉污染。作為非限制性實例，圖11I繪示帶有排氣口之實施例。 In some examples, multiple channels may be provided. In some embodiments, one channel is split into two or more channels. Optionally, some channels are split into an even greater number of channels. Some channels may include control mechanisms such as, but not limited to, valves that direct flow in the channels. At least a part of the channels may be substantially parallel to each other. Or, the non-channel parts need to be parallel to each other. In some examples, at least a portion of the channels are not parallel to each other. Alternatively, the channel may be slightly bent. Alternatively, the channel may have a cross-sectional area at a certain location and a smaller cross-sectional area at different locations along the channel. Alternatively, the channel may have a cross-sectional area at a certain location, and a larger cross-sectional area at different locations along the channel product. For some embodiments of the Y design, the channels should preferably have vents placed appropriately to define samples for each vial, thereby preventing samples from other channels or cross-contamination. As a non-limiting example, FIG. 11I illustrates an embodiment with an exhaust port.

樣本採集裝置中可提供有基座140。該基座可與支架130相連。於一些實例中，基座之一部分可為可***支架中和/或支架之一部分可為可***基座中。該基座能夠相對於支架移動。於一些實例中，樣本採集裝置可具有沿該樣本採集裝置長度延伸之縱軸。該基座和/或支架可沿縱軸方向彼此相對移動。該基座和/或支架可彼此相對移動有限距離。或者，該基座可相對於支架被固定。該基座可設於相對於具有蓋110之樣本採集裝置一端的樣本採集裝置一端。可選地，一些實施例可包括一體化基座/容器部分，因而不再有被組裝入基座件中的單獨容器。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 A base 140 may be provided in the sample collection device. The base can be connected to the bracket 130. In some examples, a portion of the base may be insertable into the support and / or a portion of the support may be insertable into the support. The base can move relative to the stand. In some examples, the sample collection device may have a longitudinal axis extending along the length of the sample collection device. The base and / or the bracket can move relative to each other along the longitudinal axis. The base and / or bracket can move a limited distance relative to each other. Alternatively, the base may be fixed relative to the bracket. The base may be disposed at the end of the sample collection device opposite to the end of the sample collection device with the cover 110. Alternatively, some embodiments may include an integrated base / container portion, so that there is no longer a separate container assembled into the base member. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

基座140其中可容納一個或多個容器。容器可與通道液體連通和/或與通道形成液體連通。通道之一端可處於容器中或可被引入容器中。基座可具有一個或多個光學指示器142a,142b，其可提供樣本是否已抵達基座中一個或多個容器的視覺指示。於一些實施例中，光學指示器可為使得使用者能夠觀察基座內部之光學窗口。光學窗口可用透明和/或半透明材料製成。或者，光學窗口可為其中無任何材料之開口。光學窗口可使使用者能夠直接觀 察基座中的容器。基座中的容器可用透明和/或半透明材料製成，使得使用者能夠觀察樣本是否已抵達基座中的容器。舉例而言，如果血液沿通道運送至容器，該等容器可視覺指示其中血液的存在。於其他實施例中，光學指示器可包括指示容器已被填滿之其他特徵。舉例而言，可於基座或容器中提供一個或多個傳感器，其可確定容器中是否已提供有足量之樣本。該一個或多個傳感器可向基座上的一個光學指示器提供信號，其可指示樣本是否已被提供至容器和/或已被提供至容器之樣本量。舉例而言，此光學指示器可包括諸如但不限於LCD顯示器、光顯示器(如LED顯示器)、等離子體熒幕等顯示器，其可指示容器是否已被充分填滿。於替代實施例中，不需提供光學指示器，而可提供替代指示器，諸如但不限於聲音指示器或溫度控制指示器，其可被用於指示容器何時被填滿。 The base 140 may accommodate one or more containers therein. The container may be in liquid communication with the channel and / or in liquid communication with the channel. One end of the channel may be in the container or may be introduced into the container. The base may have one or more optical indicators 142a, 142b, which may provide a visual indication of whether the sample has reached one or more containers in the base. In some embodiments, the optical indicator may be an optical window that allows the user to observe the interior of the base. The optical window can be made of transparent and / or translucent materials. Alternatively, the optical window may be an opening without any material therein. Optical window allows users to directly view Check the container in the base. The container in the base can be made of a transparent and / or translucent material so that the user can observe whether the sample has reached the container in the base. For example, if blood is transported along the channel to the containers, the containers can visually indicate the presence of blood therein. In other embodiments, the optical indicator may include other features that indicate that the container has been filled. For example, one or more sensors may be provided in the base or container, which may determine whether a sufficient amount of sample has been provided in the container. The one or more sensors may provide a signal to an optical indicator on the base, which may indicate whether the sample has been provided to the container and / or the amount of sample that has been provided to the container. For example, this optical indicator may include displays such as, but not limited to, LCD displays, light displays (such as LED displays), plasma screens, etc., which may indicate whether the container has been fully filled. In alternative embodiments, an optical indicator need not be provided, but an alternative indicator may be provided, such as but not limited to a sound indicator or a temperature control indicator, which may be used to indicate when the container is filled.

圖2A-2C繪示無蓋110之樣本採集裝置200。樣本採集裝置200可包括本體220、支架230及基座240。本體可與支架相連。於此實施例中，基座240可與支架在相對於與本體相連端之一端相連。本體可支持和/或容納一條、兩條或更多條通道222a,222b之至少一部分。通道可從裝置之樣本接收端226接收樣本224a,224b。 2A-2C illustrate a sample collection device 200 without a cover 110. FIG. The sample collection device 200 may include a body 220, a bracket 230, and a base 240. The body can be connected to the bracket. In this embodiment, the base 240 may be connected to the bracket at one end relative to the end connected to the body. The body may support and / or accommodate at least a portion of one, two, or more channels 222a, 222b. The channel can receive samples 224a, 224b from the sample receiving end 226 of the device.

本體220其中可具有中空部分225。或者，本體可用實心件製成。通道222a,222b可與本體一體形成。舉例而言，它們可為貫穿本體之實心部分的路徑。該路徑可經鑽孔形成，或運用微影技術形成。或者，通道可為由 本體支持之單獨結構。舉例而言，通道可為由本體支持之一個或多個軟管形成。於一些實例中，通道可於本體之實心部分被固定在位，且可穿過本體之一個或多個中空部分。可選地，本體220可由兩片結合一起形成以限定其中的通道222a和222b。 The body 220 may have a hollow portion 225 therein. Alternatively, the body can be made of solid pieces. The channels 222a, 222b may be integrally formed with the body. For example, they can be paths through solid parts of the body. The path can be formed by drilling or using lithography technology. Alternatively, the channel can be justified A separate structure supported by the ontology. For example, the channel may be formed by one or more hoses supported by the body. In some examples, the channel may be fixed in place on the solid portion of the body, and may pass through one or more hollow portions of the body. Alternatively, the body 220 may be formed by combining two pieces together to define the channels 222a and 222b therein.

通道222a,222b可包括本文他處所述之一個或多個特徵或特點。該等通道之至少一部分可相當大程度地彼此平行。或者，該等通道可彼此形成角度。於一些實施例中，該等通道可具有處於樣本採集裝置之樣本接收端226之第一端。通道之第一端可為能夠接收樣本之開放端。於一些實施例中，可於樣本採集裝置之樣本接收端設置各通道之端。一條、兩條或更多條通道可於樣本採集裝置之樣本接收端具有第一端。可採用分開之通道以最小化血液於某一通道與另一通道之間的交叉污染風險。可選地，通道可具有倒置Y型構造，其中該等通道開始為一段共同通道，隨後分開成兩條或更多條分開之通道。此Y型構造可被用於污染不成問題之情形中。可選地，Y型構造之替代方法為筆直通道，並使樣本採集器皿依序移動，與來自筆直通道之同一針頭配合。 The channels 222a, 222b may include one or more features or characteristics described elsewhere herein. At least a part of the channels can be substantially parallel to each other. Alternatively, the channels may form an angle with each other. In some embodiments, the channels may have a first end at the sample receiving end 226 of the sample collection device. The first end of the channel may be an open end capable of receiving samples. In some embodiments, the ends of the channels can be set at the sample receiving end of the sample collection device. One, two or more channels may have a first end at the sample receiving end of the sample collection device. Separate channels can be used to minimize the risk of blood cross-contamination between one channel and another channel. Alternatively, the channels may have an inverted Y configuration, where the channels start as a common channel and then split into two or more separate channels. This Y-shaped configuration can be used in situations where pollution is not a problem. Optionally, the alternative method of the Y-shaped configuration is a straight channel, and the sample collection vessel is moved in sequence to cooperate with the same needle from the straight channel.

於一些實例中，係提供有複數條通道。該等通道位於樣本接收端之末端可彼此相距很近。該等通道位於樣本接收端之末端可彼此相距相鄰。該等通道位於樣本接收端之末端可彼此相觸，或可彼此邊緣距離或中心距離小於約0.5mm、1mm、2mm、3mm、4mm、5mm、6 mm、7mm、8mm、9mm、10mm、12mm、15mm或20mm。該等通道可從樣本接收端起彼此分開。舉例而言，該等通道之相對於位於樣本接收端之末端的另一端可彼此相距更大。其彼此邊緣距離或中心距離可大於或等於約3mm、4mm、5mm、6mm、7mm、8mm、9mm、10mm、12mm、15mm、20mm、25mm或30mm。 In some examples, multiple channels are provided. The ends of the channels at the sample receiving end can be very close to each other. The ends of the channels at the sample receiving end may be adjacent to each other. The ends of the channels at the sample receiving end may touch each other, or may have an edge distance or center distance of less than about 0.5mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6 mm, 7mm, 8mm, 9mm, 10mm, 12mm, 15mm or 20mm. The channels can be separated from each other from the sample receiving end. For example, the other ends of the channels relative to the end located at the receiving end of the sample may be spaced apart from each other. The edge distance or center distance from each other may be greater than or equal to about 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, or 30 mm.

於一些實施例中，本體220可具有一種細長形狀。該本體可於或接近樣本接收端226處具有一個或多個錐形部分228。該本體側邊可於樣本接收端處交匯。所述錐形部分和/或樣本接收端可為彎曲的。或者，可設有邊緣。所述錐形部分之表面可以與裝置縱軸形成角度之方式設置。舉例而言，所述錐形部分可與縱軸形成約5度、10度、15度、30度、45度、60度或75度。 In some embodiments, the body 220 may have an elongated shape. The body may have one or more tapered portions 228 at or near the sample receiving end 226. The sides of the body can meet at the receiving end of the sample. The tapered portion and / or sample receiving end may be curved. Alternatively, an edge can be provided. The surface of the tapered portion may be arranged at an angle to the longitudinal axis of the device. For example, the tapered portion may form about 5 degrees, 10 degrees, 15 degrees, 30 degrees, 45 degrees, 60 degrees, or 75 degrees with the longitudinal axis.

裝置樣本接收端226可與樣本接觸。可直接從對象提供樣本。樣本接收端可接觸對象或樣本，該樣本正與對象接觸或正從對象中流出。舉例而言，樣本接收端可接觸對象指頭上的血滴。血液可進入通道中。血液可籍由毛細管作用、壓降、重力或任意其它動力經由通道運送。血液可從樣本接收端經由通道行至樣本交付端。樣本交付端可與裝置基座中所容納之一個或多個容器液體連通和/或與其形成液體連通。樣本可從通道進入容器中。血液可籍由壓降、毛細管作用、重力、摩擦力和/或任意其它動力被推入容器中。可選地，樣本亦可為採用吸量管、注射 器等引入之血液。應暸解，儘管圖2B繪示樣本B僅部分填充通道222a,222b，於多數實施例中，當填充過程完成後，該等通道將被樣本B全部填滿。 The device sample receiving end 226 may be in contact with the sample. Samples can be provided directly from the subject. The sample receiving end may contact an object or a sample that is in contact with or flowing out of the object. For example, the sample receiving end may contact the blood drop on the finger of the subject. Blood can enter the channel. Blood can be transported through the channel by capillary action, pressure drop, gravity, or any other power. Blood can travel from the sample receiving end to the sample delivery end via the channel. The sample delivery end may be in fluid communication with and / or in fluid communication with one or more containers contained in the base of the device. The sample can enter the container from the channel. Blood can be pushed into the container by pressure drop, capillary action, gravity, friction, and / or any other power. Alternatively, the sample can also be pipette, injection Blood introduced from the device. It should be understood that although FIG. 2B shows that the sample B only partially fills the channels 222a, 222b, in most embodiments, when the filling process is completed, the channels will be completely filled by the sample B.

圖3A-3B繪示樣本採集裝置300於使通道322a,322b與裝置基座340中所容納之一個或多個容器346a,346b形成液體連通前之實例。該樣本採集裝置可包括蓋310、本體320、支架330和基座340。本體和/或支架可支持和/或包含一條、兩條或更多條通道之至少一部分。基座可支持和/或包含一個、兩個或更多個容器。 3A-3B illustrate an example of the sample collection device 300 before the channels 322a, 322b and one or more containers 346a, 346b contained in the device base 340 are in liquid communication. The sample collection device may include a cover 310, a body 320, a bracket 330, and a base 340. The body and / or support may support and / or contain at least a portion of one, two or more channels. The base may support and / or contain one, two or more containers.

於一個實施例中，本體320和/或支架330可支持樣本採集裝置中一條或多條通道322a,322b。於一個實例中，係提供有兩條通道，惟與兩條通道之實施例相關之說明可適用於任意數目之通道，包括但不限於1、3、4、5、6或更多條通道。各條通道可具有處於裝置之樣本接收端326之第一端323a,323b。各通道之第一端可為開放式。通道可與環境空氣相通。當通道之第一端與血液等液體接觸時，該液體可被吸入通道中。可經由毛細管作用或本文他處所述之任意其它技術抽入血液。血液可沿通道長度行至通道各自之第二端325a,325b。該等通道彼此可為液體分隔。舉例而言，液體可經由第一端323a進入第一通道322a，穿過該通道之長度，並於第二端325a離開第一通道。同樣地，液體可經由第一端323b進入第二通道322b，穿過該通道之長度，並於第二端325b離開第二通道。所述第一及第二通道可為液體分隔，因而來自第一通 道之液體不通過第二通道，反之亦然。於一些實施例中，液體可不經最初離開而傳送至通道第二端。 In one embodiment, the body 320 and / or the holder 330 can support one or more channels 322a, 322b in the sample collection device. In one example, two channels are provided, but the description related to the two-channel embodiment can be applied to any number of channels, including but not limited to 1, 3, 4, 5, 6, or more channels. Each channel may have a first end 323a, 323b at the sample receiving end 326 of the device. The first end of each channel can be open. The channel can communicate with the ambient air. When the first end of the channel is in contact with a liquid such as blood, the liquid can be drawn into the channel. Blood can be drawn via capillary action or any other technique described elsewhere herein. Blood can travel along the length of the channel to the respective second ends 325a, 325b of the channel. The channels may be liquid separated from each other. For example, liquid can enter the first channel 322a through the first end 323a, pass through the length of the channel, and exit the first channel at the second end 325a. Similarly, liquid can enter the second channel 322b through the first end 323b, pass through the length of the channel, and exit the second channel at the second end 325b. The first and second channels can be separated by liquid, The liquid of the Tao does not pass through the second channel and vice versa. In some embodiments, the liquid may be transferred to the second end of the channel without initially leaving.

通道322a,322b可具有一種分離構造。舉例而言，通道之第一端323a,323b可比通道之第二端325a,325b彼此更相近。通道之第二端之間空間可大於通道之第一端之間空間。通道之第一端可能或可能不彼此接觸。通道之第一端可彼此相鄰。 The channels 322a, 322b may have a separate configuration. For example, the first ends 323a, 323b of the channel may be closer to each other than the second ends 325a, 325b of the channel. The space between the second ends of the channels may be larger than the space between the first ends of the channels. The first ends of the channels may or may not contact each other. The first ends of the channels can be adjacent to each other.

基座340可與樣本採集裝置之支架330相連。基座340可能或可能不直接接觸支架。於裝置使用期間，基座可相對於支架為可移動。於一些實施例中，基座可相對於支架沿縱向滑動。於一些實例中，基座可沿相對於支架之縱向滑動而無旋轉。於一些實例中，基座可與支架同軸滑動而無旋轉。於一些實例中，基座可相對於支架移動並同時旋轉。基座之一部分可安裝於支架之一部分中，或者反之亦然。舉例而言，基座之一部分可被***支架之一部分中和/或支架之一部分可被***基座之一部分中。可於基座和/或框架中設置一個或多個阻擋特徵，以便提供經控制的基座和支架間移動程度。阻擋特徵可包括擱架、凸出或槽。 The base 340 may be connected to the bracket 330 of the sample collection device. The base 340 may or may not directly contact the bracket. During use of the device, the base may be movable relative to the stand. In some embodiments, the base can slide longitudinally relative to the bracket. In some examples, the base can slide longitudinally relative to the stand without rotation. In some examples, the base can slide coaxially with the stand without rotation. In some examples, the base can move relative to the stand and rotate simultaneously. A part of the base can be installed in a part of the bracket, or vice versa. For example, a part of the base may be inserted into a part of the bracket and / or a part of the bracket may be inserted into a part of the base. One or more blocking features may be provided in the base and / or frame to provide a controlled degree of movement between the base and the bracket. The blocking features may include shelves, protrusions, or grooves.

基座340能夠支持一個或多個容器346a,346b。基座可具有可至少部分圍繞該一個或多個容器的外殼。於一些實例中，當基座與支架330結合時，所述容器可被完全圍繞。基座可具有一個或多個凹痕、凸出、槽或有形特徵以容納容器。基座可製成與容器形狀互補之形 狀。所述容器可維持於相對於基座豎直之位置。 The base 340 can support one or more containers 346a, 346b. The base may have a housing that may at least partially surround the one or more containers. In some examples, when the base is combined with the bracket 330, the container may be completely surrounded. The base may have one or more indentations, protrusions, grooves, or tangible features to accommodate the container. The base can be made to complement the shape of the container shape. The container can be maintained in a vertical position relative to the base.

容器係以與通道數量相等之數量提供。舉例而言，如設置有N條通道，則可提供N個容器，其中N為正整數(如1、2、3、4、5、6、7、8或更多)。各通道可對應於各自的容器。於一個實例中，樣本採集裝置可具有第一通道和第二通道，及其各自的第一容器及第二容器。第一通道322a可與第一容器346a液體連通或被配置為與其形成液體連通，第二通道322b可與第二容器346b液體連通或被配置為與其形成液體連通。 The container is provided in an amount equal to the number of channels. For example, if N channels are provided, N containers may be provided, where N is a positive integer (such as 1, 2, 3, 4, 5, 6, 7, 8, or more). Each channel may correspond to a respective container. In one example, the sample collection device may have a first channel and a second channel, and their respective first and second containers. The first channel 322a may be in liquid communication with or configured to form liquid communication with the first container 346a, and the second channel 322b may be in liquid communication with or configured to form liquid communication with the second container 346b.

於一些實施例中，各容器可具有本體349a,349b和蓋348a,348b。於一些實例中，容器本體可用一種透明或半透明材料製成。當從容器外觀察時，容器本體可允許該容器中所提供之樣本為可視。容器本體可為管狀。於一些實例中，容器本體可具有一圓柱狀部分。容器底部可為平坦、錐形、圓形或其任意組合。容器可具有一開放端和一封閉端。開放端可為容器之頂端，其可位於容器更接近一條或多條通道之一端。封閉端可為容器之底端，其可位於容器更遠離一條或多條通道之一端。本文他處可更詳細地說明容器之各種實施例。 In some embodiments, each container may have a body 349a, 349b and a lid 348a, 348b. In some examples, the container body can be made of a transparent or translucent material. When viewed from outside the container, the container body may allow the sample provided in the container to be visible. The container body may be tubular. In some examples, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered, round, or any combination thereof. The container may have an open end and a closed end. The open end may be the top of the container, which may be located at one end of the container closer to one or more channels. The closed end may be the bottom end of the container, which may be located at one end of the container further away from one or more channels. Other embodiments of the container can be described in more detail elsewhere herein.

基座340可具有一個或多個光學指示器，諸如光學窗口342a,342b。所述光學窗口可位於容器346a,346b上。於一些實例中，所述光學窗口可位於容器本體上。透過單個窗口可觀察單個容器或多個容器。於一個實例中，係可提供與容器相同數量之光學窗口。各光學窗口 可對應於各自的容器。光學窗口及容器均可用光透射材料製成，以允許使用者觀察樣本是否已自樣本採集裝置外抵達容器。 The base 340 may have one or more optical indicators, such as optical windows 342a, 342b. The optical window may be located on the container 346a, 346b. In some examples, the optical window may be located on the container body. A single window or multiple containers can be viewed through a single window. In one example, the same number of optical windows as the container can be provided. Optical windows Can correspond to the respective container. Both the optical window and the container can be made of a light-transmitting material to allow the user to observe whether the sample has reached the container from outside the sample collection device.

於一些實施例中，係有通道322a及322b之光學窗口，以便使用者可觀察通道中何時達到所需填充程度。一些實施例中本體320為完全透明或半透明，沿通道係有標記或指示標記以觀察何時達到所需填充程度。 In some embodiments, optical windows of channels 322a and 322b are provided so that the user can observe when the desired filling level in the channels is reached. In some embodiments, the body 320 is completely transparent or translucent, and marks or indicator marks are attached along the channel to observe when the desired filling level is reached.

容器大小可設為包含小體積液體樣本。於一些實施例中，容器可被配置為包含不超過約5ml、4ml、3ml、2ml、1.5mL、1mL、900uL、800uL、700uL、600uL、500uL、400uL、300uL、250uL、200uL、150uL、100uL、80uL、50uL、30uL、25uL、20uL、10uL、7uL、5uL、3uL、2uL、1uL、750nL、500nL、250nL、200nL、150nL、100nL、50nL、10nL、5nL或1nL。容器可被配置為包含不超過數滴血液、一滴血液或不超過一滴血液之一部分。 The size of the container can be set to contain a small volume of liquid sample. In some embodiments, the container may be configured to contain no more than about 5 ml, 4 ml, 3 ml, 2 ml, 1.5 mL, 1 mL, 900 uL, 800 uL, 700 uL, 600 uL, 500 uL, 400 uL, 300 uL, 250 uL, 200 uL, 150 uL, 100 uL, 80uL, 50uL, 30uL, 25uL, 20uL, 10uL, 7uL, 5uL, 3uL, 2uL, 1uL, 750nL, 500nL, 250nL, 200nL, 150nL, 100nL, 50nL, 10nL, 5nL or 1nL. The container may be configured to contain no more than a few drops of blood, a drop of blood, or a portion of no more than one drop of blood.

容器可包括蓋348a,348b。插塞可被配置為套至容器之開放端。所述蓋可堵塞容器之開放端。所述蓋可液體密封容器。所述蓋可與容器本體形成液體密封。舉例而言，氣體和/或液體不可滲透所述蓋。或者，所述蓋可允許特定氣體和/或液體通過。於一些實例中，所述蓋可為氣體可滲透而液體不可滲透。所述蓋可為樣本不可滲透。舉例而言，全血、血清或血漿不可滲透所述蓋。於一些實例中，所述蓋之一部分可配合進入容器本體之一部分 中。所述蓋可與容器本體形成一個制止器。所述蓋可包括可懸掛於容器本體之一部分上之唇狀結構或擱架。此唇狀結構或擱架可防止所述蓋滑入容器本體中。於一些實例中，蓋之一部分可覆蓋於容器本體之頂部和/或側部。本文中有關容器之任何說明均可適用於與樣本採集裝置之組合。可選地，一些實施例於器皿組合中可包括諸如蓋座等額外部件。於一個實施例中，所述蓋座之用途為維持所述蓋與容器之間的緊密密封。於一個實施例中，所述蓋座與附件、唇狀結構、凹痕或容器外面上其它附件位置配合，將所述蓋固定在位。可選地，一些實施例可將所述蓋及蓋座之功能合併於一個部件中。 The container may include lids 348a, 348b. The plug can be configured to fit over the open end of the container. The lid can block the open end of the container. The lid may liquid seal the container. The lid may form a liquid seal with the container body. For example, gases and / or liquids are impermeable to the cover. Alternatively, the cover may allow certain gases and / or liquids to pass through. In some examples, the cover may be gas permeable and liquid impermeable. The cover may be impermeable to the sample. For example, whole blood, serum, or plasma is impermeable to the cap. In some examples, a part of the lid may fit into a part of the container body in. The lid may form a stopper with the container body. The lid may include a lip-like structure or shelf that can be hung on a portion of the container body. This lip-like structure or shelf prevents the lid from sliding into the container body. In some examples, a portion of the lid may cover the top and / or sides of the container body. Any description of the container in this article can be applied in combination with the sample collection device. Optionally, some embodiments may include additional components such as lid holders in the vessel combination. In one embodiment, the purpose of the lid holder is to maintain a tight seal between the lid and the container. In one embodiment, the cover seat cooperates with attachments, lip structures, dents, or other attachment positions on the outside of the container to secure the cover in place. Optionally, some embodiments may combine the functions of the cover and the cover seat into one component.

可提供一個或多個配合組合。所述配合組合可包括通道支座350和/或施力部件，如彈簧352或彈性。於一個實施例中，所述支座350可將轉接通道354固定於支架上。正如本文他處所述，轉接通道354可與採集通道一體形成或可為獨立件、採集通道一部分，或容器一部分之單獨元件。於一個實施例中，所述支座350可防止轉接通道354相對於支架滑動。所述支座350可選地提供彈簧等施力部件可安置於其上之支架。 One or more combinations can be provided. The mating combination may include a channel support 350 and / or a force-applying member, such as a spring 352 or elasticity. In one embodiment, the support 350 can fix the adapter channel 354 on the bracket. As described elsewhere herein, the transition channel 354 may be integral with the collection channel or may be a separate piece, part of the collection channel, or a separate element of the container. In one embodiment, the support 350 can prevent the adapter channel 354 from sliding relative to the bracket. The support 350 may optionally provide a bracket on which a biasing member such as a spring can be placed.

於一個實例中，所述配合組合可各自包括彈簧352，其可施加作用力使得基座340處於延伸狀態，而彈簧則處於其自然狀態。當基座處於其延伸狀態時，容器346a,346b與所述配合組合之間係提供有空間。於一些實例中，當基座340處於其延伸狀態時，通道第二端可能或 可能不接觸容器蓋。通道第二端325a,325b可處於不與容器內部液體連通之位置。 In one example, the mating combinations may each include springs 352, which may exert a force so that the base 340 is in an extended state, while the springs are in their natural state. When the base is in its extended state, a space is provided between the containers 346a, 346b and the mating combination. In some examples, when the base 340 is in its extended state, the second end of the channel may or May not touch container lid. The second end 325a, 325b of the channel may be in a position that is not in liquid communication with the interior of the container.

樣本採集裝置可具有任意數量之配合組合。舉例而言，可提供與通道數量相同之配合組合。各通道可具有一個配合組合。舉例而言，如果提供有第一通道和第二通道，則可為第一通道提供第一配合組合，並為第二通道提供第二配合組合。可提供相同數量之配合組合及容器。 The sample collection device can have any number of combinations. For example, the same number of matching combinations as the number of channels can be provided. Each channel can have a matching combination. For example, if a first channel and a second channel are provided, a first mating combination may be provided for the first channel, and a second mating combination may be provided for the second channel. Can provide the same number of matching combinations and containers.

於一個實施例中，配合組合可容納一條轉接通道354，諸如但不限於具有彎曲、錐形或尖銳末端327a和327b之細長部件。應暸解，於一些實施例中，末端327a和327b為與通道322a和322b分開形成並隨後耦合於通道322a和322b之針頭的一部分。所述針頭可用與限定通道322a和322b之本體相同或不同之材料製成。舉例而言，一些實施例可使用一種金屬製成針頭，而使用聚合體或塑料材料製成限定通道322a和322b之本體。可選地，一些實施例可於與通道322a和322b一體形成之部件上製成末端327a和327b。於一些實例中，通道第二端可被配置為穿透一種材料，如容器之蓋348a,348b。於一些實施例中，轉接通道354之一部分可被***採集通道或採集通道之一部分可被***轉接通道，或此兩種方式均可被配置，並對準對齊。可選地，一些實施例可將轉接通道354與採集通道322a一體形成。應暸解，圖3B(及4B)繪示樣本B僅部分填充通道122a,122b，但是於多數實施例中，當填充過程完成後，該等通道將被樣本B全部填滿。可對本 文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 In one embodiment, the mating combination can accommodate an adapter channel 354, such as but not limited to an elongated member with curved, tapered, or sharp ends 327a and 327b. It should be appreciated that in some embodiments, the ends 327a and 327b are part of a needle that is formed separately from the channels 322a and 322b and then coupled to the channels 322a and 322b. The needle may be made of the same or different material as the body defining the channels 322a and 322b. For example, some embodiments may use a metal for the needle and a polymer or plastic material for the body defining the channels 322a and 322b. Alternatively, some embodiments may make the ends 327a and 327b on a component integrally formed with the channels 322a and 322b. In some examples, the second end of the channel may be configured to penetrate a material, such as the lids 348a, 348b of the container. In some embodiments, a part of the transition channel 354 can be inserted into the acquisition channel or a part of the collection channel can be inserted into the transition channel, or both methods can be configured and aligned. Optionally, in some embodiments, the conversion channel 354 and the collection channel 322a may be integrally formed. It should be understood that FIG. 3B (and 4B) shows that the sample B only partially fills the channels 122a, 122b, but in most embodiments, when the filling process is completed, the channels will be completely filled by the sample B. Available for this The embodiments described herein are changed or replaced, and all embodiments should not be interpreted as covering all inventions.

圖4A-4B繪示具有與裝置中容器446a,446b內部液體連通之通道422a,422b的樣本採集裝置400之實例。該樣本採集裝置可包括蓋410、本體420、支架430和基座440。本體和/或支架可支持和/或包含一條、兩條或更多條通道之至少一部分。基座可支持和/或包含一個、兩個或更多個容器。 4A-4B illustrate an example of a sample collection device 400 having channels 422a, 422b in fluid communication with the interior of containers 446a, 446b in the device. The sample collection device may include a cover 410, a body 420, a bracket 430, and a base 440. The body and / or support may support and / or contain at least a portion of one, two or more channels. The base may support and / or contain one, two or more containers.

於一個實施例中，本體420和/或支架430可支持樣本採集裝置中一條或多條通道422a,422b。舉例而言，係提供有第一通道和第二通道。各條通道可具有處於裝置之樣本接收端426之第一端423a,423b。各通道之第一端可為開放式。通道可與環境空氣相通。當通道之第一端與血液等液體接觸時，該液體可被吸入通道中。可經由毛細管作用或本文他處所述之任意其它技術抽入液體。液體可沿通道長度行至通道各自之第二端425a,425b。於一些實施例中，液體可籍由毛細管作用或本文所述其它技術抵達通道第二端。於其它實施例中，液體不需要抵達通道第二端。所述通道可為彼此液體分隔。 In one embodiment, the body 420 and / or the bracket 430 may support one or more channels 422a, 422b in the sample collection device. For example, the first channel and the second channel are provided. Each channel may have a first end 423a, 423b at the sample receiving end 426 of the device. The first end of each channel can be open. The channel can communicate with the ambient air. When the first end of the channel is in contact with a liquid such as blood, the liquid can be drawn into the channel. Liquid can be drawn in via capillary action or any other technique described elsewhere herein. The liquid can travel along the length of the channel to the respective second ends 425a, 425b of the channel. In some embodiments, the liquid may reach the second end of the channel by capillary action or other techniques described herein. In other embodiments, the liquid need not reach the second end of the channel. The channels may be liquid separated from each other.

於一些實施例中，當所述通道與容器446a,446b內部不液體連通時，液體可不經離開而傳送至通道第二端。舉例而言，液體可籍由毛細管作用被抽入通道中，該毛細管作用可使得液體流至或流近所述通道末端，而不造成液體離開所述通道。 In some embodiments, when the channel is not in liquid communication with the interior of the containers 446a, 446b, the liquid may be transferred to the second end of the channel without leaving. For example, liquid can be drawn into the channel by capillary action, which can cause liquid to flow to or near the end of the channel without causing the liquid to leave the channel.

基座440可與樣本採集裝置之支架430相連。於裝置使用期間，基座可相對於支架為可移動。於一些實施例中，基座可相對於支架沿縱向滑動。於一個實例中，所述基座可具有(i)通道與容器內部不液體連通之延伸位置，及(ii)通道與容器內部液體連通之壓縮位置。樣本採集裝置可最初處於延伸狀態，如圖3所示。當樣本被採集並流過通道長度後，使用者可推入基座，使樣本採集裝置進入其壓縮狀態，如圖4所示。一旦基座被推入，所述基座可自然地保持被推入狀態，或一旦推動力被移開後，即可彈回至延伸狀態。於一些實例中，基座可被拉出至延伸狀態，或可被完全拉出以提供至其中容器之通路。 The base 440 may be connected to the bracket 430 of the sample collection device. During use of the device, the base may be movable relative to the stand. In some embodiments, the base can slide longitudinally relative to the bracket. In one example, the base may have (i) an extended position where the channel is not in liquid communication with the interior of the container, and (ii) a compressed position where the channel is in liquid communication with the interior of the container. The sample collection device may initially be in an extended state, as shown in FIG. 3. After the sample is collected and flows through the length of the channel, the user can push it into the base to put the sample collection device into its compressed state, as shown in FIG. 4. Once the base is pushed in, the base can naturally be kept pushed in, or once the pushing force is removed, it can spring back to the extended state. In some examples, the base can be pulled out to an extended state, or can be pulled out completely to provide access to the container therein.

基座440能夠支持一個或多個容器446a,446b。基座可具有可至少部分圍繞該一個或多個容器的外殼。於一些實例中，當基座與支架430結合時，所述容器可被完全圍繞。基座可具有一個或多個凹痕、凸出、槽或有形特徵以容納容器。基座可製成與容器形狀互補之形狀。所述容器可維持於相對於基座豎直之位置。 The base 440 can support one or more containers 446a, 446b. The base may have a housing that may at least partially surround the one or more containers. In some examples, when the base is combined with the bracket 430, the container may be completely surrounded. The base may have one or more indentations, protrusions, grooves, or tangible features to accommodate the container. The base can be made complementary to the shape of the container. The container can be maintained in a vertical position relative to the base.

容器係以與通道數量相等之數量提供。各通道可對應於各自的容器。於一個實例中，樣本採集裝置可具有第一通道和第二通道，及其各自的第一容器及第二容器。第一通道422a可與第一容器446a液體連通或被配置為與其形成液體連通，第二通道422b可與第二容器446b液體連通或被配置為與其形成液體連通。第一通道最初可與第一容器不液體連通，第二通道最初可與第二容器不液 體連通。當基座相對於支架被推入時，第一和第二通道即可與第一和第二容器內部分別形成液體連通。第一和第二通道可同時與第一和第二容器形成液體連通。或者，它們不一定同時形成液體連通。形成液體連通之時機可取決於通道第二端和容器之間的相對距離。 The container is provided in an amount equal to the number of channels. Each channel may correspond to a respective container. In one example, the sample collection device may have a first channel and a second channel, and their respective first and second containers. The first channel 422a may be in liquid communication with or configured to form liquid communication with the first container 446a, and the second channel 422b may be in liquid communication with or configured to form liquid communication with the second container 446b. The first channel may initially be in liquid communication with the first container, and the second channel may initially be in liquid communication with the second container 体 连接。 Body connection. When the base is pushed in relative to the bracket, the first and second channels can form liquid communication with the inside of the first and second containers, respectively. The first and second channels may be in liquid communication with the first and second containers simultaneously. Alternatively, they do not necessarily form liquid communication at the same time. The timing of liquid communication may depend on the relative distance between the second end of the channel and the container.

於一些實施例中，各容器可具有本體449a,449b和蓋448a,448b。容器本體可為管狀。於一些實例中，容器本體可具有一圓柱狀部分。容器底部可為平坦、錐形、圓形或其任意組合。容器可具有一開放端和一封閉端。開放端可為容器之頂端，其可位於容器更接近一條或多條通道之一端。封閉端可為容器之底端，其可位於容器更遠離一條或多條通道之一端。 In some embodiments, each container may have a body 449a, 449b and a lid 448a, 448b. The container body may be tubular. In some examples, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered, round, or any combination thereof. The container may have an open end and a closed end. The open end may be the top of the container, which may be located at one end of the container closer to one or more channels. The closed end may be the bottom end of the container, which may be located at one end of the container further away from one or more channels.

基座440可具有一個或多個光學指示器，諸如光學窗口442a,442b。所述光學窗口可位於容器446a,446b上。於一些實例中，所述光學窗口可位於容器本體上。光學窗口及容器均可用光透射材料製成，以允許使用者觀察樣本是否已自樣本採集裝置外抵達容器。於一些實施例中，容器可於容器本身之上帶有標記指示填充程度要求。 The base 440 may have one or more optical indicators, such as optical windows 442a, 442b. The optical window may be located on the container 446a, 446b. In some examples, the optical window may be located on the container body. Both the optical window and the container can be made of a light-transmitting material to allow the user to observe whether the sample has reached the container from outside the sample collection device. In some embodiments, the container may be marked on the container itself to indicate the filling level requirements.

容器可包括蓋448a,448b。所述蓋可被配置為套至容器之開放端。所述蓋可堵塞容器之開放端。所述蓋可液體密封容器。所述蓋可與容器本體形成液體密封。舉例而言，全血、血清或血漿不可滲透所述蓋。於一些實例中，所述蓋之一部分可配合進入容器本體之一部分中。所 述蓋可包括可懸掛於容器本體之一部分上之唇狀結構或擱架。於一些實施例中，所述蓋可具有中空或凹陷。所述中空或凹陷可有助於引導通道第二端至所述蓋之中心。於一些實例中，當樣本採集裝置處於延伸狀態時，通道425a,425b之第二端可位於容器蓋之上。所述通道第二端可能或可能不接觸所述容器蓋。於一些實例中，所述通道第二端可置於所述蓋之中空或凹陷內。於一些實例中，所述通道第二端可部分地穿透所述蓋而不抵達容器內部。可選地，所述蓋之一些實施例可包括波形皺縮件以維持真空。 The container may include lids 448a, 448b. The lid may be configured to fit over the open end of the container. The lid can block the open end of the container. The lid may liquid seal the container. The lid may form a liquid seal with the container body. For example, whole blood, serum, or plasma is impermeable to the cap. In some examples, a portion of the lid may fit into a portion of the container body. Place The lid may include a lip structure or a shelf that may be suspended from a portion of the container body. In some embodiments, the cover may have a hollow or depression. The hollow or recess may help guide the second end of the channel to the center of the cover. In some examples, when the sample collection device is in the extended state, the second ends of the channels 425a, 425b may be located above the container lid. The second end of the channel may or may not contact the container lid. In some examples, the second end of the channel may be placed in a hollow or recess in the cover. In some examples, the second end of the channel may partially penetrate the lid without reaching the interior of the container. Optionally, some embodiments of the cover may include a corrugated shrink member to maintain a vacuum.

通道第二端可具有彎曲、錐形或尖銳末端427a和427b。應暸解，於一些實施例中，末端427a和427b為與通道422a和422b分開形成並隨後耦合於通道422a和422b之針頭的一部分。所述針頭可用與限定通道422a和422b之本體相同或不同之材料製成。舉例而言，一些實施例可使用一種金屬製成針頭，而使用聚合體或塑料材料製成限定通道422a和422b之本體。可選地，一些實施例可於與通道422a和422b一體形成之部件上製成末端427a和427b。於一些實例中，通道第二端可被配置為穿透一種材料，如容器之蓋448a,448b。所述蓋可用一種可防止樣本於不存在穿透件之情形下穿過的材料製成。所述蓋可由單片實心件製成。或者，所述蓋可包括一個可接收穿透件之狹縫、開口、孔、薄部分或任意其他特徵。當穿透件不處於狹縫或開口中時，或當穿透件被從狹縫或開口中移走時，狹縫或其它開口能夠將樣本保持於其中。於一些實例 中，所述蓋可用一種自修復材料製成，由此當穿透件被移走時，因穿透件而形成之開口封閉。通道第二端可為可穿過所述蓋並進入容器內部之穿透件。於一些實施例中，應明確的是，所述穿透件可為允許樣本穿過之中空針頭，而不僅為用於穿刺之針頭。於一些實施例中，該穿刺端可為一種非去芯設計，諸如但不限於一種錐形插管，其穿刺時不去除蓋材料。 The second end of the channel may have curved, tapered or sharp ends 427a and 427b. It should be appreciated that in some embodiments, the ends 427a and 427b are part of a needle formed separately from the channels 422a and 422b and then coupled to the channels 422a and 422b. The needle may be made of the same or different material as the body defining the channels 422a and 422b. For example, some embodiments may use a metal for the needle and a polymer or plastic material for the body defining the channels 422a and 422b. Alternatively, some embodiments may make the ends 427a and 427b on a component integrally formed with the channels 422a and 422b. In some examples, the second end of the channel may be configured to penetrate a material, such as the lids 448a, 448b of the container. The cover can be made of a material that prevents the sample from passing through without the penetrating member. The cover may be made from a single piece of solid piece. Alternatively, the cover may include a slit, opening, hole, thin portion or any other feature that can receive the penetrating member. When the penetrating member is not in the slit or opening, or when the penetrating member is removed from the slit or opening, the slit or other opening can hold the sample therein. Some examples In this case, the cover may be made of a self-healing material, so that when the penetrating member is removed, the opening formed by the penetrating member is closed. The second end of the channel may be a penetrating member that can pass through the lid and enter the interior of the container. In some embodiments, it should be clear that the penetrating member may be a hollow needle that allows the sample to pass through, not just a needle used for puncture. In some embodiments, the puncture end may be a non-coreless design, such as but not limited to a tapered cannula, which does not remove the cover material when puncturing.

可提供一個或多個配合組合。所述配合組合可包括通道支座450和/或施力部件，如彈簧452或彈性。於一個實施例中，所述支座450可將轉接通道454固定於支架上。正如本文他處所述，轉接通道454可與採集通道一體形成或可為獨立件、採集通道一部分，或容器一部分之單獨元件。於一個實施例中，所述支座450可防止轉接通道454相對於支架滑動。所述支座450可選地提供彈簧等施力部件可安置於其上之支架。 One or more combinations can be provided. The mating combination may include a channel support 450 and / or a force applying member, such as a spring 452 or elasticity. In one embodiment, the support 450 can fix the adapter channel 454 on the bracket. As described elsewhere herein, the transition channel 454 may be integrally formed with the collection channel or may be a separate piece, part of the collection channel, or a separate element of the container. In one embodiment, the support 450 can prevent the adapter channel 454 from sliding relative to the bracket. The support 450 may optionally provide a bracket on which a biasing member such as a spring can be placed.

於一個實例中，所述配合組合可各自包括彈簧452，其可施加作用力使得基座處於延伸狀態，而彈簧則處於其自然狀態。當基座處於其延伸狀態時，容器446a,446b與所述配合組合之間係提供有空間。通道425a,425b之第二端可處於不與容器內部液體連通之位置。 In one example, the mating combinations may each include springs 452, which may exert a force so that the base is in an extended state, while the springs are in their natural state. When the base is in its extended state, a space is provided between the containers 446a, 446b and the mating combination. The second ends of the channels 425a, 425b may be in a position not to communicate with the liquid inside the container.

樣本採集裝置可具有任意數量之配合組合。舉例而言，可提供與通道數量相同之配合組合。各通道可具有一個配合組合。舉例而言，如果提供有第一通道和第二通道，則可為第一通道提供第一配合組合，並為第二通道 提供第二配合組合。於一個實施例中，可提供相同數量之配合組合及容器。 The sample collection device can have any number of combinations. For example, the same number of matching combinations as the number of channels can be provided. Each channel can have a matching combination. For example, if a first channel and a second channel are provided, the first channel may be provided with a first combination and the second channel Provide a second combination. In one embodiment, the same number of matching combinations and containers can be provided.

當基座被壓入時，彈簧452可被壓縮。通道第二端425a,425b可穿透容器蓋。通道第二端可進入容器內部。於一些實例中，可提供一種力使液體被驅離通道，進入容器。舉例而言，可於通道第一及第二端之間產生壓降。可於通道第一端423a,423b施加正壓，和/或可於通道第二端施加負壓。所述正壓可相對於通道第二端和/或環境大氣為正。所述負壓可相對於通道第一端和/或環境大氣為負。於一個實例中，容器其中可具有真空。當通道第二端穿透容器時，容器中之負壓可將樣本抽入容器中。於替代實施例中，樣本可籍由毛細管力、重力或任意其它動力推動進入容器中。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 When the base is pressed in, the spring 452 may be compressed. The second end 425a, 425b of the channel can penetrate the container lid. The second end of the channel can enter the interior of the container. In some examples, a force may be provided to drive the liquid away from the channel and into the container. For example, a pressure drop can be generated between the first and second ends of the channel. A positive pressure may be applied to the first end 423a, 423b of the channel, and / or a negative pressure may be applied to the second end of the channel. The positive pressure may be positive relative to the second end of the channel and / or the ambient atmosphere. The negative pressure may be negative relative to the first end of the channel and / or the ambient atmosphere. In one example, the container may have a vacuum therein. When the second end of the channel penetrates the container, the negative pressure in the container can draw the sample into the container. In alternative embodiments, the sample may be pushed into the container by capillary force, gravity, or any other power. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

於一些實例中，可於樣本採集之不同階段採用不同類型之動力。由此，某種類型之動力可被用於抽吸樣本入通道中，隨後另一不同類型之動力可被用於從通道中抽吸樣本入容器。舉例而言，毛細管力可將樣本抽入通道中，而壓降可推動樣本離開通道，進入容器。可採用任意動力組合抽吸樣本入通道及容器中。於一些實施例中，抽吸樣本入通道中之動力不同於抽吸樣本入容器中之動力。於一些替代實施例中，各階段可採用相同之動力。於一些實施例中，依序或於限定時間施加動力。作為非限制性實例，直至至少一條通道已達到最低填充程度時，方才施加 抽吸樣本入容器中之動力。可選地，直至至少兩條通道均已達到各自最低填充程度時，方才施加抽吸樣本入容器中之動力。可選地，直至所有通道均已達到各自最低填充程度時，方才施加抽吸樣本入容器中之動力。於一些實施例中，同時施加所述動力。 In some examples, different types of power may be used at different stages of sample collection. Thus, a certain type of power can be used to draw the sample into the channel, and then a different type of power can be used to draw the sample from the channel into the container. For example, capillary force can draw the sample into the channel, and the pressure drop can push the sample out of the channel and into the container. Any power combination can be used to draw the sample into the channel and container. In some embodiments, the power to draw the sample into the channel is different from the power to draw the sample into the container. In some alternative embodiments, the same power may be used in each stage. In some embodiments, the power is applied sequentially or at a defined time. As a non-limiting example, it is not applied until at least one channel has reached the minimum filling level The power to draw the sample into the container. Optionally, the motive force for drawing the sample into the container is not applied until at least two channels have reached their respective minimum filling levels. Optionally, the motive force for drawing the sample into the container is not applied until all channels have reached their respective minimum filling levels. In some embodiments, the power is applied simultaneously.

一些實施例可採用與樣本採集裝置耦合之加壓氣體源，所述氣體源被配置為將所採集體液從所述一條或多條通道推入其各自容器中。可選地，一些實施例可採用不與容器相關之真空源將樣本液體朝容器抽吸。 Some embodiments may employ a pressurized gas source coupled to the sample collection device, the gas source configured to push the collected body fluid from the one or more channels into their respective containers. Alternatively, some embodiments may use a vacuum source that is not associated with the container to draw the sample liquid toward the container.

另外，通道之一些實施例可被配置，使得通道中具有充分毛細管力，當其被填滿時，該力大於重力，由此樣本無法僅因重力即排離通道。須使用額外動力突破通道毛細作用之控制。可選地，如本文他處所述，諸如但不限於套管之裝置可防止體液從最接近容器一端排出通道，由此將轉移至容器前之任何損失降至最低。 In addition, some embodiments of the channel can be configured so that there is sufficient capillary force in the channel, and when it is filled, the force is greater than gravity, so that the sample cannot be discharged from the channel solely by gravity. It is necessary to use extra power to break through the capillary control of the channel. Alternatively, as described elsewhere herein, devices such as but not limited to cannulas can prevent body fluids from exiting the channel closest to the end of the container, thereby minimizing any loss before transfer to the container.

可選地，可採用諸如但不限於液圈、海綿或其它動力提供者等其它材料，提供將樣本抽吸入容器之動力。當多種力同時被運用時，這可為將樣本抽吸入容器之首要、第二或第三動力。可選地，一些實施例可包括推動型動力提供者，諸如但不限於以所需方式移動樣本之活塞。 Alternatively, other materials such as, but not limited to, liquid rings, sponges, or other power providers may be used to provide the power to draw the sample into the container. When multiple forces are applied simultaneously, this can be the primary, secondary, or tertiary force for drawing the sample into the container. Optionally, some embodiments may include a push-type power provider, such as but not limited to a piston that moves the sample in a desired manner.

當樣本被引入通道並沿通道長度移動後，可能已過了一段時間。使用者可將樣本引入樣本採集裝置，並等待樣本沿通道長度移動。可提供一個或多個光學指示 器，其可指示樣本是否達到所需填充程度，比如但不限於通道末端。於其他實施例中，使用者可等待預定時間，然後推入基座。當使用者判定樣本業已移動了足夠的通道長度和/或自引入樣本以來已過了充分長的時間，所述基座即可被推入。所述基座被推入後，可使通道與容器形成液體連通，且樣本可從通道流入容器中。可提供光學指示器，以便使用者可了解容器何時被填滿。 When the sample is introduced into the channel and moved along the length of the channel, it may have been a while. The user can introduce the sample into the sample collection device and wait for the sample to move along the length of the channel. Can provide one or more optical indicators It can indicate whether the sample has reached the required filling level, such as but not limited to the end of the channel. In other embodiments, the user can wait for a predetermined time before pushing into the base. When the user determines that the sample has moved a sufficient channel length and / or a sufficient time has passed since the sample was introduced, the base can be pushed in. After the base is pushed in, the channel and the container can be in liquid communication, and the sample can flow from the channel into the container. An optical indicator can be provided so that the user can know when the container is filled.

容器被裝滿後，即可採用本文他處所述之系統及方法轉運至所需地點。於一些實例中，可轉運整個樣本採集裝置。所述蓋可被置於樣本採集裝置上用於轉運。於其他實施例中，基座部分和/或支架部分可與裝置其他部分分開。於一個實例中，基座可從樣本採集裝置上移除，且容器可與基座同時轉運。或者，基座可從樣本採集裝置上移除，以便提供至容器之通路，而容器即可從裝置上移除，隨後發運。基座移除可包括樣本採集裝置之部分分解，以便拆卸基座。這可涉及運用充分的力克服裝置的防止意外脫離之自帶卡位或制動部件。可選地，使用者於移除基座前可採取一些其他積極行動，諸如但不限於解除鎖扣或其他鎖定機制。可選地，一些實施例可允許不經移除基座即可移除容器，其留有透過基座上開口、進入孔或可打開蓋接觸容器之通道。 Once the container is filled, it can be transferred to the desired location using the systems and methods described elsewhere herein. In some examples, the entire sample collection device can be transported. The cover can be placed on the sample collection device for transfer. In other embodiments, the base portion and / or the bracket portion may be separate from other parts of the device. In one example, the base can be removed from the sample collection device, and the container can be transported simultaneously with the base. Alternatively, the base can be removed from the sample collection device to provide access to the container, and the container can be removed from the device before shipping. Removal of the base may include partial disassembly of the sample collection device to disassemble the base. This may involve applying sufficient force to overcome the device's own detent or brake components that prevent accidental disengagement. Optionally, the user may take some other positive actions before removing the base, such as but not limited to unlocking the buckle or other locking mechanism. Optionally, some embodiments may allow the container to be removed without removing the base, which leaves access to the container through an opening in the base, an access hole, or an openable lid.

於一些實施例中，一個或多個通道和/或容器可包括本文他處所述特徵，諸如分離部件、塗層、抗凝劑、微珠或任意其他特徵。於一個實例中，引入樣本採集 裝置之樣本可為全血。可提供有兩條通道及各自容器。於此非限制性實例中，各條通道均具有塗層，諸如但不限於通道中的抗凝劑塗層。此類抗凝劑塗層可實現以下功能之一或更多。第一，抗凝劑可防止全血於樣本採集過程中在通道中凝固。視所需採集全血量，凝固可能於足量的血液被引入通道前堵塞通道。另一功能為將抗凝劑引入全血樣本中。籍由於通道中提供抗凝劑，此工藝與僅於容器446a或446b中提供抗凝劑的一些實施例相比，可更早地開始採集程序。早期引入抗凝劑還可於以下情形中具有優點，即全血樣本將沿其中部分未塗覆有抗凝劑之路徑流動，所述部分包括但不限於與通道422a或422b相連之針頭內表面。可選地，一些實施例可包括用於改動表面接觸角度(可濕性)之介面活性劑。 In some embodiments, one or more channels and / or containers may include features described elsewhere herein, such as separation components, coatings, anticoagulants, microbeads, or any other features. In one example, introduce sample collection The sample of the device may be whole blood. Two channels and respective containers can be provided. In this non-limiting example, each channel has a coating, such as but not limited to an anticoagulant coating in the channel. Such anticoagulant coatings can perform one or more of the following functions. First, anticoagulants can prevent whole blood from clotting in the channel during sample collection. Depending on the amount of blood collected, clotting may block the channel before sufficient blood is introduced into the channel. Another function is to introduce anticoagulants into the whole blood sample. Since the anticoagulant is provided in the channel, this process can start the collection procedure earlier than in some embodiments where only the anticoagulant is provided in the container 446a or 446b. The early introduction of anticoagulants may also have the advantage that the whole blood sample will flow along a path where some of the anticoagulant is not coated, including but not limited to the inner surface of the needle connected to the channel 422a or 422b . Optionally, some embodiments may include a surfactant for modifying the surface contact angle (wetability).

於一些實施例中，通道之內表面和/或沿液體路徑之其他表面，諸如但不限於至樣本採集器皿內部之樣本進口，可塗覆有一種介面活性劑和/或抗凝劑溶液。所述介面活性劑為液體裝置之恐水層提供可濕表面，並幫助血液等液體樣本填充計量通道。抗凝劑溶液有助於防止血液等樣本進入液體裝置時發生堵塞。可運用之示例性介面活性劑包括但不限於提供介面活性劑之合適潤濕特性的吐溫、TWEEN®20、Thesit®、脫氧膽酸鈉、Triton、Triton®X-100、Pluronic和/或其他非溶血清潔劑。EDTA及肝磷脂為可使用之非限制性抗凝劑。於一個非限制性實例中，實施例溶液包括2%吐溫、50%甲醇/50% H20中之25mg/mL EDTA，其隨後晾乾。甲醇/水混合物提供了溶解EDTA及吐溫之手段，且可於塑料表面快速晾乾。所述溶液可籍由任意技術塗覆於通道或沿液體流動路徑之其他表面上，如移液、噴塗或吸收等所述技術將確保需塗覆表面形成均勻薄膜。 In some embodiments, the inner surface of the channel and / or other surfaces along the liquid path, such as but not limited to the sample inlet into the sample collection vessel, may be coated with a surfactant and / or anticoagulant solution. The interface active agent provides a wettable surface for the water-repellent layer of the liquid device, and helps liquid samples such as blood fill the metering channel. The anticoagulant solution helps prevent clogging when blood and other samples enter the liquid device. Exemplary surfactants that may be used include, but are not limited to, Tween, TWEEN® 20, Thesit®, sodium deoxycholate, Triton, Triton® X-100, Pluronic, and / or others that provide suitable wetting properties of the surfactant Non-hemolytic cleaner. EDTA and heparin are non-limiting anticoagulants that can be used. In a non-limiting example, the example solution includes 2% Tween, 50% methanol / 50% 25 mg / mL EDTA in H20, which was then air dried. The methanol / water mixture provides a means of dissolving EDTA and Tween, and can be quickly dried on the plastic surface. The solution can be applied to the channel or other surface along the liquid flow path by any technique, such as pipetting, spraying, or absorption, etc. The technique will ensure that a uniform film is formed on the surface to be coated.

還應暸解，本文所述任意實施例中，通道塗層可延伸至通道全長。可選地，塗層可覆蓋多數，而不是全部通道。可選地，一些實施例可不塗覆最接近進入開口之通道區域，以最小化交叉污染風險，即其中來自某一通道之塗覆材料籍由所有通道同時與目標樣本液體接觸之時進入附近通道中，由此形成連接液體路徑。 It should also be understood that in any of the embodiments described herein, the channel coating may extend over the entire length of the channel. Alternatively, the coating may cover most, but not all channels. Optionally, some embodiments may not coat the channel area closest to the entry opening to minimize the risk of cross-contamination, that is, where the coating material from a channel enters a nearby channel when all channels are in contact with the target sample liquid In this way, a connecting liquid path is formed.

儘管本文所述實施例於樣本採集裝置中具有兩條單獨通道，應暸解，一些實施例可運用兩條以上之單獨通道。可選地，一些實施例可運用少於兩條完全分離之通道。一些實施例可僅使用一條單獨通道。可選地，一些實施例可運用倒置Y型通道，其起始為一條通道，隨後分開成兩條或更多條通道。這些概念中任一個均可適用於本文所述其他實施例中。 Although the embodiments described herein have two separate channels in the sample collection device, it should be understood that some embodiments may utilize more than two separate channels. Alternatively, some embodiments may use less than two completely separated channels. Some embodiments may use only a single channel. Alternatively, some embodiments may use an inverted Y-shaped channel that starts with one channel and then splits into two or more channels. Any of these concepts can be applied to other embodiments described herein.

具有自支持採集通道之採集裝置Acquisition device with self-supporting acquisition channel

圖5A-5B提供依據本文所述實施例之樣本採集裝置500的又一實例。所述樣本採集裝置可包括採集裝置本體520、支架530及基座540。於一些實例中，可選地提供有蓋。該採集裝置本體可包括由採集管限定且能夠接收 樣本之一條或多條採集路徑522a,522b。基座可具有一個或多個光學指示器542a,542b，其可提供有關樣本是否到達基座中所容納之一個或多個容器的視覺指示。支架可具有一個或多個光學指示器532a,532b，其可提供有關樣本是否到達或通過通道一部分的視覺指示。 5A-5B provide yet another example of a sample collection device 500 according to embodiments described herein. The sample collection device may include a collection device body 520, a bracket 530, and a base 540. In some examples, a cover is optionally provided. The body of the collection device may include a collection tube defined and capable of receiving One or more collection paths 522a, 522b of the sample. The base may have one or more optical indicators 542a, 542b, which may provide a visual indication as to whether the sample has reached one or more containers contained in the base. The holder may have one or more optical indicators 532a, 532b, which may provide a visual indication as to whether the sample has reached or passed through a portion of the channel.

樣本採集裝置之採集裝置本體520係可包含一個或多個其中具有通道522a,522b的管的至少一部分。可選地，採集裝置本體520還可限定與由所述管限定之通道522a,522b耦合之通道。於一些實施例中，通道一部分可延伸超出採集裝置本體。所述通道可延伸超出採集裝置本體之一端或兩端。 The collection device body 520 of the sample collection device may include at least a portion of one or more tubes having channels 522a, 522b therein. Optionally, the collection device body 520 may also define a channel coupled with the channels 522a, 522b defined by the tube. In some embodiments, a portion of the channel can extend beyond the body of the collection device. The channel may extend beyond one or both ends of the body of the collection device.

採集裝置本體520係可與支架530相連。所述支架其中可包含一條或多條通道之一部分。採集裝置本體係可永久地固定於支架上或可相對於支架被移除。於一些實例中，採集裝置本體及支架可由單個一體化部件形成。或者，採集裝置本體及支架可由不同部件形成。 The collection device body 520 can be connected to the bracket 530. The bracket may include a part of one or more channels. Collection device The system can be permanently fixed on the stand or can be removed relative to the stand. In some examples, the collection device body and the stand may be formed from a single integrated component. Alternatively, the collection device body and the bracket may be formed from different components.

於該裝置運行過程中，該採集裝置本體520與該支架530可彼此相對移動。於一些實例中，本體520之一部分可為可***支架530中和/或支架之一部分可為可***本體中。所述本體能夠相對於支架移動。於一些實例中，樣本採集裝置可具有沿該樣本採集裝置長度延伸之縱軸。該本體和/或支架可沿縱軸方向彼此相對移動。該本體和/或支架可彼此相對移動有限距離。該本體和/或支架可同軸移動，而無旋轉移動。或者，可提供有旋轉移動。 During the operation of the device, the collection device body 520 and the support 530 can move relative to each other. In some examples, a portion of the body 520 may be insertable into the holder 530 and / or a portion of the holder may be insertable into the body. The body can move relative to the bracket. In some examples, the sample collection device may have a longitudinal axis extending along the length of the sample collection device. The body and / or the bracket can move relative to each other along the longitudinal axis. The body and / or the bracket can move a limited distance relative to each other. The body and / or the bracket can move coaxially without rotational movement. Alternatively, rotational movement may be provided.

該採集裝置本體520可由一種光透射材料製成。舉例而言，此採集裝置本體可由一種透明或半透明材料製成。或者，該本體可由一種不透明材料製成。支架530可由一種光學不透明、半透明或透明材料製成。該支架可能或可能不具有與採集裝置本體相同之光學特徵。該支架可由一種與採集裝置本體不同之材料或一種與採集裝置本體相同之材料製成。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 The collection device body 520 may be made of a light-transmitting material. For example, the body of the collection device can be made of a transparent or translucent material. Alternatively, the body may be made of an opaque material. The bracket 530 may be made of an optically opaque, translucent, or transparent material. The holder may or may not have the same optical characteristics as the body of the collection device. The bracket can be made of a material different from the body of the collection device or a material the same as the body of the collection device. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

採集裝置本體520、支架和/或基座可為任意形狀或尺寸。於一些實例中，採集裝置本體、支架和/或基座可為圓形、橢圓形、三角形、四邊形(如正方形、長方形、梯形)、五邊形、六邊形、八邊形或任意其它剖面形狀。此剖面形狀沿長度可保持不變或可變化。採集裝置本體、支架和基座之剖面形狀可為相同或可不相同。於一些實例中，採集裝置本體、支架和/或基座可具有小於或等於約10cm²、7cm²、5cm²、4cm²、3cm²、2.5cm²、2cm²、1.5cm²、1cm²、0.8cm²、0.5cm²、0.3cm²或0.1cm²之剖面面積。此剖面面積沿長度可保持不變或可變化。採集裝置本體、支架和基座之剖面面積可為相同或可不相同。該採集裝置本體、支架和/或基座可具有小於或等於約20cm、15cm、12cm、10cm、9cm、8cm、7cm、6cm、5cm、4cm、3cm、2cm、1cm、0.5cm或0.1cm之長度。該採集裝置本體可具有比支架或基座更大或更小之長度，或具有與支架或基座相等之長度。 The collection device body 520, the bracket and / or the base may be of any shape or size. In some examples, the collection device body, support, and / or base may be circular, oval, triangular, quadrangular (such as square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-section shape. The cross-sectional shape can be kept constant or variable along the length. The cross-sectional shapes of the collection device body, the bracket and the base may be the same or may be different. In some examples, the collection device body, bracket, and / or base may have less than or equal to about 10 cm ² , 7 cm ² , 5 cm ² , 4 cm ² , 3 cm ² , 2.5 cm ² , 2 cm ² , 1.5 cm ² , 1 cm ² , The cross-sectional area of 0.8cm ² , 0.5cm ² , 0.3cm ² or 0.1cm ² . The cross-sectional area can be kept constant or variable along the length. The cross-sectional areas of the collection device body, the bracket and the base may be the same or may be different. The collection device body, support, and / or base may have a length less than or equal to about 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or 0.1 cm . The body of the collection device may have a larger or smaller length than the bracket or base, or have a length equal to that of the bracket or base.

通道522a,522b可籍由裝置本體520和/或支架530支持。於一些實例中，其中管或通道之整長可被包含於裝置本體與支架之組合中。或者，如圖5所示，通道可延伸超出裝置本體和/或支架。於一些實例中，通道可延伸超出裝置本體/支架組合之一端，或超出兩端。通道位置可籍由裝置本體和/或支架固定。於一些實例中，通道可被固定於裝置本體和/或相對於裝置本體不移動。通道可相對於支架移動。於一些實例中，係提供複數條通道。所述通道至少一部分可彼此為相當大程度地平行。所述通道可彼此平行和/或平行於沿樣本採集裝置長度延伸之縱軸。或者，無通道部分需要彼此平行。於一些實例中，所述通道至少一部分彼此不平行。所述通道可為略有彎曲。可選地，其可為筆直，惟於接近樣本採集點處，彼此靠得更近。應暸解，限定通道522a和522b之管可由光學透明、透射或其他材料製成，可充分提供樣本於至少一條通道中達到所需填充程度之可檢測變化。可選地，此可檢測變化可被用於檢測何時兩條通道均達到至少所需填充程度。 The channels 522a, 522b may be supported by the device body 520 and / or the bracket 530. In some examples, the entire length of the tube or channel may be included in the combination of the device body and the stand. Alternatively, as shown in FIG. 5, the channel may extend beyond the device body and / or the bracket. In some examples, the channel may extend beyond one end of the device body / bracket combination, or beyond both ends. The channel position can be fixed by the device body and / or the bracket. In some examples, the channel may be fixed to the device body and / or not move relative to the device body. The channel is movable relative to the bracket. In some examples, multiple channels are provided. At least a part of the channels may be substantially parallel to each other. The channels can be parallel to each other and / or parallel to the longitudinal axis extending along the length of the sample collection device. Or, the non-channel parts need to be parallel to each other. In some examples, at least a portion of the channels are not parallel to each other. The channel may be slightly curved. Alternatively, it may be straight, but closer to each other near the sample collection point. It should be understood that the tubes defining the channels 522a and 522b may be made of optically transparent, transmissive, or other materials, which can sufficiently provide a detectable change in the degree of filling of the sample in at least one channel. Alternatively, this detectable change can be used to detect when both channels have reached at least the required filling level.

樣本採集裝置中可提供有基座540。該基座可與支架530相連。於一些實例中，基座540之一部分可為可***支架530中和/或支架之一部分可為可***基座中。該基座可相對於支架為固定或相對於支架可移動。該基座可設於相對於與本體連接的支架一端的支架一端。基座可由獨立於支架之部件製成。基座可從支架上分開。或者， 基座可固定於支架和/或與支架形成一體化部件。 A base 540 may be provided in the sample collection device. The base can be connected to the bracket 530. In some examples, a portion of the base 540 may be insertable into the bracket 530 and / or a portion of the bracket may be insertable into the base. The base can be fixed relative to the bracket or movable relative to the bracket. The base may be provided at one end of the bracket relative to one end of the bracket connected to the body. The base can be made of components independent of the bracket. The base can be separated from the stand. or, The base may be fixed to the bracket and / or form an integrated component with the bracket.

基座540其中可容納一個或多個容器。容器可與通道液體連通和/或與通道形成液體連通。通道之一端可處於容器中或可被引入容器中。基座可具有一個或多個光學指示器542a,542b，其可提供樣本是否已抵達基座中一個或多個容器的視覺指示。於一些實施例中，光學指示器可為使得使用者能夠觀察基座內部之光學窗口。光學窗口可用透明和/或半透明材料製成。或者，光學窗口可為其中無任何材料之開口。光學窗口可使使用者能夠直接觀察基座中的容器。基座中的容器可用透明和/或半透明材料製成，使得使用者能夠觀察樣本是否已抵達基座中的容器。舉例而言，如果血液沿通道運送至容器，該等容器可展示其中的血液。於其他實施例中，光學指示器可包括指示容器已被填滿之其他特徵。舉例而言，可於基座或容器中提供一個或多個傳感器，其可確定容器中是否已提供有充量之樣本。所述傳感器可向基座上的一個光學指示器提供信號，其可指示樣本是否已被提供至容器和/或已被提供至容器之樣本量。舉例而言，此光學指示器可包括諸如LCD顯示器、光顯示器(如LED顯示器)、等離子體熒幕等顯示器，其可指示容器是否已被充分填滿。於替代實施例中，不需提供光學指示器，而可提供替代指示器，諸如但不限於聲音指示器、溫度控制指示器或其他裝置，其可籍由使用者可檢測的信號等可檢測信號指示容器何時被填滿。 The base 540 can accommodate one or more containers therein. The container may be in liquid communication with the channel and / or in liquid communication with the channel. One end of the channel may be in the container or may be introduced into the container. The base may have one or more optical indicators 542a, 542b, which may provide a visual indication of whether the sample has reached one or more containers in the base. In some embodiments, the optical indicator may be an optical window that allows the user to observe the interior of the base. The optical window can be made of transparent and / or translucent materials. Alternatively, the optical window may be an opening without any material therein. The optical window allows the user to directly observe the container in the base. The container in the base can be made of a transparent and / or translucent material so that the user can observe whether the sample has reached the container in the base. For example, if blood is transported along the channel to the containers, the containers can display the blood therein. In other embodiments, the optical indicator may include other features that indicate that the container has been filled. For example, one or more sensors may be provided in the base or container, which may determine whether a filled sample has been provided in the container. The sensor may provide a signal to an optical indicator on the base, which may indicate whether the sample has been provided to the container and / or the amount of sample that has been provided to the container. For example, this optical indicator may include a display such as an LCD display, a light display (such as an LED display), a plasma screen, etc., which may indicate whether the container has been fully filled. In alternative embodiments, an optical indicator need not be provided, but an alternative indicator may be provided, such as but not limited to a sound indicator, a temperature control indicator, or other device, which may be detectable by a signal detectable by the user Indicates when the container is filled.

支架530可具有一個或多個光學指示器532a,532b，其可提供有關樣本是否到達或通過支架所容納通道一部分的視覺指示。於一些實施例中，光學指示器可為使得使用者能夠觀察支架內部之光學窗口。光學窗口可用透明和/或半透明材料製成。或者，光學窗口可為其中無任何材料之開口。光學窗口可使使用者能夠直接觀察支架中通道之一部分。通道可用透明和/或半透明材料製成，使得使用者能夠觀察樣本是否已抵達光學窗口之下的所述通道一部分。於其他實施例中，光學指示器可包括指示樣本已通過所述通道一部分的其他特徵，例如本文他處所述傳感器。 The holder 530 may have one or more optical indicators 532a, 532b, which may provide a visual indication as to whether the sample has reached or passed through a portion of the channel contained in the holder. In some embodiments, the optical indicator may be an optical window that enables the user to observe the interior of the stand. The optical window can be made of transparent and / or translucent materials. Alternatively, the optical window may be an opening without any material therein. The optical window allows the user to directly observe a part of the channel in the bracket. The channel may be made of transparent and / or translucent materials, so that the user can observe whether the sample has reached a part of the channel under the optical window. In other embodiments, the optical indicator may include other features that indicate that the sample has passed through a portion of the channel, such as sensors described elsewhere herein.

現請參考圖6A-6B，係依據本文所述實施例，提供樣本採集裝置500的更多視圖。 Referring now to FIGS. 6A-6B, according to the embodiments described herein, more views of the sample collection device 500 are provided.

於一些實施例中，容納通道522a,522b之管的一部分可延伸超出採集裝置本體520。延伸超出之通道部分可包括被配置為從對象接收樣本之通道部分。於一個實例中，所述通道可具有作為通道樣本接收端的第一端523a,523b。 In some embodiments, a portion of the tube containing the channels 522a, 522b may extend beyond the collection device body 520. The channel portion extending beyond may include a channel portion configured to receive a sample from the subject. In one example, the channel may have first ends 523a, 523b as channel sample receiving ends.

所述通道可選地由剛性材料限定。或者，所述通道可由柔性材料限定或可具有柔性部件。所述通道可能或可能不設計為彎曲或成曲形。所述通道可能或可能不彼此相當大程度地平行。於一些實例中，所述通道第一端可於鬆弛狀態中彼此分開一定距離。所述通道第一端可於裝置操作過程中保持該距離。或者，可使所述通道第一端更 接近。舉例而言，所述通道第一端可被壓至一起。所述通道的各開放端可分別接收樣本。樣本可依序接收。樣本可來自同一對象。或者，所述通道能夠同時接收同一樣本。 The channel is optionally defined by a rigid material. Alternatively, the channel may be defined by a flexible material or may have flexible components. The channel may or may not be designed to be curved or curved. The channels may or may not be substantially parallel to each other. In some examples, the first ends of the channels may be separated from each other by a certain distance in a relaxed state. The first end of the channel can maintain this distance during operation of the device. Alternatively, the first end of the channel can be changed Close. For example, the first ends of the channels can be pressed together. Each open end of the channel can receive samples separately. Samples can be received in order. The sample can be from the same subject. Alternatively, the channel can receive the same sample at the same time.

通道522a,522b可包括本文他處所述之一個或多個特徵或特點。該等通道之至少一部分可相當大程度彼此平行。或者，該等通道可彼此形成角度。於一些實施例中，該等通道可具有處於樣本採集裝置之樣本接收端526之第一端。通道之第一端可為能夠接收樣本之開放端。於一些實施例中，可於樣本採集裝置之樣本接收端設置各通道之端。一條、兩條或更多條通道可於樣本採集裝置之樣本接收端具有第一端。 The channels 522a, 522b may include one or more features or characteristics described elsewhere herein. At least a part of the channels may be parallel to each other to a considerable extent. Alternatively, the channels may form an angle with each other. In some embodiments, the channels may have a first end at the sample receiving end 526 of the sample collection device. The first end of the channel may be an open end capable of receiving samples. In some embodiments, the ends of the channels can be set at the sample receiving end of the sample collection device. One, two or more channels may have a first end at the sample receiving end of the sample collection device.

於一些實施例中，裝置本體520可相對於支架530為可移動。裝置本體之一部分可為可***支架中，或反之亦然。於一個實例中，裝置本體可具有唇狀結構527及內部529。所述唇狀結構可具有大於所述內部之剖面面積。所述內部能夠被***支架中。所述唇狀結構可作為阻擋防止整個本體被***支架中。所述唇狀結構可置於支架的一個肩部。 In some embodiments, the device body 520 may be movable relative to the bracket 530. A part of the device body may be insertable into the stand, or vice versa. In one example, the device body may have a lip structure 527 and an interior 529. The lip structure may have a larger cross-sectional area than the interior. The interior can be inserted into the bracket. The lip structure can act as a barrier to prevent the entire body from being inserted into the stent. The lip structure can be placed on one shoulder of the bracket.

圖7A-7B繪示係依據本文所述實施例所提供樣本採集裝置700實例的局部剖視圖。樣本採集裝置處於延伸狀態，通道722a,722b與裝置基座740中容納的一個或多個容器746a,746b還未形成液體連通。樣本採集裝置可包括本體720、支架730及基座740。本體和/或支架可支持和/或包含一條本體、兩條或更多條通道之至少一部 分。基座可支持和/或包含一個、兩個或更多個容器。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 7A-7B are partial cross-sectional views of an example of a sample collection device 700 provided according to embodiments described herein. The sample collection device is in an extended state, and the channels 722a, 722b and the one or more containers 746a, 746b contained in the device base 740 have not formed liquid communication. The sample collection device may include a body 720, a bracket 730, and a base 740. The body and / or bracket can support and / or contain at least one of a body, two or more channels Minute. The base may support and / or contain one, two or more containers. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

於一個實施例中，本體720和/或支架730可支持樣本採集裝置中一條或多條通道722a,722b。於一個實例中，係提供有兩條通道，惟與兩條通道之實施例相關之說明可適用於任意數目之通道，包括但不限於1、3、4、5、6或更多條通道。各條通道可具有可作為裝置樣本接收端之第一端723a,723b。各通道之第一端可為開放式。通道可與環境空氣相通。當通道第一端與血液等液體接觸時，該液體可被吸入通道中。可經由毛細管作用或本文他處所述之任意其它技術抽入血液。液體可沿通道長度行至通道各自之第二端。該等通道彼此可為液體分隔。舉例而言，液體可經由第一端723a進入第一通道722a，穿過該通道之長度，並於第二端離開第一通道。同樣地，液體可經由第一端723b進入第二通道722b，穿過該通道之長度，並於第二端離開第二通道。所述第一及第二通道可為液體分隔，因而來自第一通道之液體不通過第二通道，反之亦然。於一些實施例中，液體可不經最初離開而傳送至通道第二端。 In one embodiment, the body 720 and / or the bracket 730 can support one or more channels 722a, 722b in the sample collection device. In one example, two channels are provided, but the description related to the two-channel embodiment can be applied to any number of channels, including but not limited to 1, 3, 4, 5, 6, or more channels. Each channel may have a first end 723a, 723b that can serve as a sample receiving end of the device. The first end of each channel can be open. The channel can communicate with the ambient air. When the first end of the channel comes into contact with liquid such as blood, the liquid can be drawn into the channel. Blood can be drawn via capillary action or any other technique described elsewhere herein. The liquid can travel along the length of the channel to each second end of the channel. The channels may be liquid separated from each other. For example, liquid can enter the first channel 722a through the first end 723a, pass through the length of the channel, and exit the first channel at the second end. Similarly, liquid can enter the second channel 722b through the first end 723b, pass through the length of the channel, and exit the second channel at the second end. The first and second channels may be separated by liquid, so liquid from the first channel does not pass through the second channel and vice versa. In some embodiments, the liquid may be transferred to the second end of the channel without initially leaving.

通道722a,722b可具有平行配置。舉例而言，通道第一端723a,723b彼此分開之距離可與通道第二端彼此分開之距離大約相同。通道第一端可能或可能不彼此接觸。 The channels 722a, 722b may have a parallel configuration. For example, the first ends 723a, 723b of the channel may be separated from each other by about the same distance as the second ends of the channel. The first ends of the channels may or may not contact each other.

支架730可具有一個或多個光學指示器，諸如光學窗口732a,732b。所述光學窗口可位於通道722a,722b上。於一些實例中，所述光學窗口可位於通道之部分上。透過單個窗口可觀察單個通道部分或多個通道部分。於一個實例中，係可提供與通道相同數量之光學窗口。各光學窗口可對應於各自的通道。光學窗口及通道均可用光透射材料製成，以允許使用者觀察樣本是否已自樣本採集裝置外抵達和/或通過下面之通道部分。此類判定可對判定何時壓縮樣本採集裝置有用。 The bracket 730 may have one or more optical indicators, such as optical windows 732a, 732b. The optical window may be located on the channels 722a, 722b. In some examples, the optical window may be located on a portion of the channel. A single window section or multiple channel sections can be observed through a single window. In one example, the same number of optical windows as channels can be provided. Each optical window may correspond to a respective channel. Both the optical window and the channel can be made of a light-transmitting material to allow the user to observe whether the sample has arrived from outside the sample collection device and / or passed through the lower channel part. Such a determination may be useful for determining when to compress the sample collection device.

基座740可與樣本採集裝置之支架730相連。基座可能或可能不直接接觸支架。於裝置使用期間，基座可相對於支架為固定。於一些實例中，基座可從支架上移除。基座之一部分可被***支架中和/或反之亦然。於一些實施例中，基座可沿相對於支架之縱向從支架滑出。於一些實例中，基座可與支架同軸滑動而無旋轉。於一些實例中，基座可相對於支架移動並同時旋轉。 The base 740 can be connected to the bracket 730 of the sample collection device. The base may or may not directly contact the stand. During use of the device, the base can be fixed relative to the support. In some examples, the base can be removed from the stand. A part of the base can be inserted into the bracket and / or vice versa. In some embodiments, the base can slide out of the bracket in a longitudinal direction relative to the bracket. In some examples, the base can slide coaxially with the stand without rotation. In some examples, the base can move relative to the stand and rotate simultaneously.

基座740能夠支持一個或多個容器746a,746b。基座可具有可至少部分圍繞該一個或多個容器的外殼。於一些實例中，當基座與支架730結合時，所述容器可被完全圍繞。基座高度可延伸超出容器高度。或者，基座高度可延伸至與容器高度相等或較低的程度。基座可具有一個或多個凹痕、凸出、槽或有形特徵以容納容器。基座可製成與容器形狀互補之形狀。舉例而言，基座可具有一個或多個管形凹痕，供管形容器恰好放入。容器亦可與 基座形成摩擦配合。所述容器可維持於相對於基座豎直之位置。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 The base 740 can support one or more containers 746a, 746b. The base may have a housing that may at least partially surround the one or more containers. In some examples, when the base is combined with the bracket 730, the container may be completely surrounded. The height of the base can extend beyond the height of the container. Alternatively, the height of the base may extend to a level equal to or lower than the height of the container. The base may have one or more indentations, protrusions, grooves, or tangible features to accommodate the container. The base can be made complementary to the shape of the container. For example, the base may have one or more tubular indentations for the tubular container to fit into. The container can also be The base forms a friction fit. The container can be maintained in a vertical position relative to the base. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

容器係以與通道數量相等之數量提供。舉例而言，如設置有N條通道，則可提供N個容器，其中N為正整數(如1、2、3、4、5、6、7、8或更多)。各通道可對應於各自的容器。於一個實例中，樣本採集裝置可具有第一通道和第二通道，及其各自的第一容器及第二容器。第一通道722a可與第一容器746a液體連通或被配置為與其形成液體連通，第二通道722b可與第二容器746b液體連通或被配置為與其形成液體連通. The container is provided in an amount equal to the number of channels. For example, if N channels are provided, N containers may be provided, where N is a positive integer (such as 1, 2, 3, 4, 5, 6, 7, 8, or more). Each channel may correspond to a respective container. In one example, the sample collection device may have a first channel and a second channel, and their respective first and second containers. The first channel 722a may be in liquid communication with the first container 746a or configured to form liquid communication therewith, the second channel 722b may be in liquid communication with the second container 746b or configured to form liquid communication therewith.

於一些實施例中，各容器可具有本體749a,749b和蓋748a,748b。所述容器可具有本文他處可所述之任意特徵或特性。 In some embodiments, each container may have a body 749a, 749b and a lid 748a, 748b. The container may have any of the features or characteristics described elsewhere herein.

基座740可具有一個或多個光學指示器，諸如光學窗口742a,742b。所述光學窗口可位於容器746a,746b上。於一些實例中，所述光學窗口可位於容器本體上。透過單個窗口可觀察單個容器或多個容器。於一個實例中，係可提供與容器相同數量之光學窗口。各光學窗口可對應於各自的容器。光學窗口及容器均可用光透射材料製成，以允許使用者觀察樣本是否已自樣本採集裝置外抵達容器。此類視覺評估可對判定樣本何時抵達容器，及何時可從樣本採集裝置上移除基座有用。 The base 740 may have one or more optical indicators, such as optical windows 742a, 742b. The optical window may be located on the container 746a, 746b. In some examples, the optical window may be located on the container body. A single window or multiple containers can be viewed through a single window. In one example, the same number of optical windows as the container can be provided. Each optical window may correspond to a respective container. Both the optical window and the container can be made of a light-transmitting material to allow the user to observe whether the sample has reached the container from outside the sample collection device. Such visual assessment may be useful for determining when the sample arrives at the container and when the base can be removed from the sample collection device.

可提供一個或多個配合組合。所述配合組合可 包括通道支座750和/或施力部件，如彈簧752或彈性。於一個實施例中，所述支座750可將轉接通道754固定於支架上。正如本文他處所述，轉接通道754可與採集通道一體形成或可為獨立件、採集通道一部分，或容器一部分之單獨元件。於一個實施例中，所述支座750可防止轉接通道754相對於支架滑動。所述支座750可選地提供彈簧等施力部件可安置於其上之支架。 One or more combinations can be provided. The combination can be Including channel support 750 and / or force-applying components, such as spring 752 or elastic. In one embodiment, the support 750 can fix the adapter channel 754 on the bracket. As described elsewhere herein, the transition channel 754 may be integrally formed with the collection channel or may be a separate piece, part of the collection channel, or a separate element of the container. In one embodiment, the support 750 can prevent the adapter channel 754 from sliding relative to the bracket. The support 750 may optionally provide a bracket on which a biasing member such as a spring can be placed.

於一個實例中，所述配合組合可包括彈簧752，其可施加作用力使得本體720處於延伸狀態，而彈簧則處於其自然狀態。當本體處於其延伸狀態時，容器746a,746b與所述配合組合之間係提供有空間。當本體處於其延伸狀態時，本體內部729可被暴露和/或不被支架730覆蓋。於一些實例中，當基座處於其延伸狀態時，通道722a,722b第二端可能或可能不接觸容器蓋。通道第二端可處於不與容器內部液體連通之位置。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 In one example, the mating combination may include a spring 752, which may apply a force such that the body 720 is in an extended state, while the spring is in its natural state. When the body is in its extended state, a space is provided between the container 746a, 746b and the mating combination. When the body is in its extended state, the interior 729 of the body may be exposed and / or not covered by the bracket 730. In some examples, when the base is in its extended state, the second ends of the channels 722a, 722b may or may not contact the container lid. The second end of the channel may be in a position that is not in liquid communication with the interior of the container. The embodiments described herein can be changed or replaced, and all embodiments should not be construed as covering all inventions.

樣本採集裝置可具有任意數量之配合組合。舉例而言，可提供與通道數量相同之配合組合。各通道可具有一個配合組合。舉例而言，如果提供有第一通道和第二通道，則可為第一通道提供第一配合組合，並為第二通道提供第二配合組合。可提供相同數量之配合組合及容器。 The sample collection device can have any number of combinations. For example, the same number of matching combinations as the number of channels can be provided. Each channel can have a matching combination. For example, if a first channel and a second channel are provided, a first mating combination may be provided for the first channel, and a second mating combination may be provided for the second channel. Can provide the same number of matching combinations and containers.

圖8A-8B繪示具有與其中容器846a,846b內部液體連通之通道822a,822b的樣本採集裝置800之實例。 樣本採集裝置可包括本體820、支架830及基座840。本體和/或支架可支持和/或包含一條本體、兩條或更多條通道之至少一部分。通道可延伸超出本體一端。基座可支持和/或包含一個、兩個或更多個容器。 8A-8B illustrate an example of a sample collection device 800 having channels 822a, 822b in liquid communication with the interior of the containers 846a, 846b. The sample collection device may include a body 820, a bracket 830, and a base 840. The body and / or support may support and / or contain at least a portion of one body, two or more channels. The channel can extend beyond one end of the body. The base may support and / or contain one, two or more containers.

於一個實施例中，本體820和/或支架830可支持樣本採集裝置中一條或多條通道822a,822b。舉例而言，係提供有第一通道和第二通道。各條通道可具有處於裝置之樣本接收端之第一端823a,823b，其可延伸超出本體。各通道之第一端可為開放式。通道可與環境空氣相通。通道可為剛性或可為柔性。於一些實施例中，通道可具有使其能夠彎曲從而彼此相接觸之長度。當通道之第一端與血液等液體接觸時，該液體可被吸入通道中。各通道可分別與液體接觸，其被分別抽吸入各條通道。這可涉及傾斜樣本採集裝置，使得任何時刻僅有一條通道開口與樣本液體接觸。或者，所有通道可同時與同一樣本接觸，其被同時抽吸入各通道中。或者，多個卻不是全部通道可同時與同一樣本接觸，其隨後被同時抽吸入各通道中。可經由毛細管作用或本文他處所述之任意其它技術抽入液體。液體可沿通道長度行至通道各自之第二端。於一些實施例中，液體可籍由毛細管作用或本文所述其它技術抵達通道第二端。於其它實施例中，液體不需要抵達通道第二端。所述通道可為彼此液體分隔。 In one embodiment, the body 820 and / or the support 830 may support one or more channels 822a, 822b in the sample collection device. For example, the first channel and the second channel are provided. Each channel may have a first end 823a, 823b at the sample receiving end of the device, which may extend beyond the body. The first end of each channel can be open. The channel can communicate with the ambient air. The channel may be rigid or may be flexible. In some embodiments, the channels may have a length that allows them to bend to contact each other. When the first end of the channel is in contact with a liquid such as blood, the liquid can be drawn into the channel. Each channel can be in contact with the liquid, which is drawn into each channel separately. This may involve tilting the sample collection device so that only one channel opening is in contact with the sample liquid at any time. Alternatively, all channels can be in contact with the same sample at the same time, which is simultaneously drawn into each channel. Alternatively, multiple but not all channels may be in contact with the same sample at the same time, which is then drawn into each channel simultaneously. Liquid can be drawn in via capillary action or any other technique described elsewhere herein. The liquid can travel along the length of the channel to each second end of the channel. In some embodiments, the liquid may reach the second end of the channel by capillary action or other techniques described herein. In other embodiments, the liquid need not reach the second end of the channel. The channels may be liquid separated from each other.

於一些實施例中，當所述通道與容器846a,846b內部不液體連通時，液體可不經離開而傳送至通道第 二端。舉例而言，液體可籍由毛細管作用被抽入通道中，該毛細管作用可使得液體流至或流近所述通道末端，而不造成液體離開所述通道。 In some embodiments, when the channel is not in liquid communication with the interior of the container 846a, 846b, the liquid may be transferred to the channel without leaving Two ends. For example, liquid can be drawn into the channel by capillary action, which can cause liquid to flow to or near the end of the channel without causing the liquid to leave the channel.

於裝置使用期間，本體820可相對於支架830為可移動。於一些實施例中，本體可相對於支架沿縱向滑動。於一個實例中，所述本體可具有(i)通道與容器內部不液體連通之延伸位置，及(ii)通道與容器內部液體連通之壓縮位置。樣本採集裝置可最初處於延伸狀態，如圖7所示。當樣本被採集並流過通道長度後，使用者可推入本體，使樣本採集裝置進入其壓縮狀態，如圖8所示。於一些實例中，當本體處於延伸狀態，本體之內部被暴露。當本體處於壓縮狀態，本體之內部可被支架覆蓋。本體之唇狀結構可接觸支架。一旦本體被推入，所述本體可自然地保持被推入狀態，或一旦推動力被移開後，即可彈回至延伸狀態。於一些實例中，本體可被拉出至延伸狀態，或可被完全拉出以提供至其中容器之通路。可選地，於一些組合中，移開本體將不提供至容器之通路。 During use of the device, the body 820 may be movable relative to the bracket 830. In some embodiments, the body can slide longitudinally relative to the bracket. In one example, the body may have (i) an extended position where the channel is not in liquid communication with the interior of the container, and (ii) a compressed position where the channel is in liquid communication with the interior of the container. The sample collection device may initially be in an extended state, as shown in FIG. 7. After the sample is collected and flows through the length of the channel, the user can push the body into the compressed state of the sample collection device, as shown in FIG. 8. In some examples, when the body is in the extended state, the inside of the body is exposed. When the body is in a compressed state, the inside of the body can be covered by the bracket. The lip-like structure of the body can contact the bracket. Once the body is pushed in, the body can naturally remain pushed in, or once the pushing force is removed, it can spring back to the extended state. In some examples, the body can be pulled out to an extended state, or can be pulled out completely to provide access to the container therein. Optionally, in some combinations, removing the body will not provide access to the container.

基座840可與樣本採集裝置之支架830相連。基座840能夠支持一個或多個容器846a,846b。基座可具有可至少部分圍繞該一個或多個容器的外殼。於一些實例中，當基座與支架830結合時，所述容器可被完全圍繞。基座可具有一個或多個凹痕、凸出、槽或有形特徵以容納容器。基座可製成與容器形狀互補之形狀。所述容器可維持於相對於基座豎直之位置。 The base 840 may be connected to the bracket 830 of the sample collection device. The base 840 can support one or more containers 846a, 846b. The base may have a housing that may at least partially surround the one or more containers. In some examples, when the base is combined with the bracket 830, the container may be completely surrounded. The base may have one or more indentations, protrusions, grooves, or tangible features to accommodate the container. The base can be made complementary to the shape of the container. The container can be maintained in a vertical position relative to the base.

容器係以與通道數量相等之數量提供。各通道可對應於各自的容器。於一個實例中，樣本採集裝置可具有第一通道和第二通道，及其各自的第一容器及第二容器。第一通道822a可與第一容器846a液體連通或被配置為與其形成液體連通，第二通道822b可與第二容器846b液體連通或被配置為與其形成液體連通。第一通道最初可與第一容器不液體連通，第二通道最初可與第二容器不液體連通。當本體相對於支架被推入時，第一和第二通道即可與第一和第二容器內部分別形成液體連通。第一和第二通道可同時與第一和第二容器形成液體連通。或者，它們不一定同時形成液體連通。形成液體連通之時機可取決於容器高度和/或通道長度。形成液體連通之時機可取決於通道第二端和容器之間的相對距離。 The container is provided in an amount equal to the number of channels. Each channel may correspond to a respective container. In one example, the sample collection device may have a first channel and a second channel, and their respective first and second containers. The first channel 822a may be in liquid communication with or configured to form liquid communication with the first container 846a, and the second channel 822b may be in liquid communication with or configured to form liquid communication with the second container 846b. The first channel may initially be in non-liquid communication with the first container, and the second channel may initially be in non-liquid communication with the second container. When the body is pushed in relative to the bracket, the first and second channels can form liquid communication with the inside of the first and second containers, respectively. The first and second channels may be in liquid communication with the first and second containers simultaneously. Alternatively, they do not necessarily form liquid communication at the same time. The timing of liquid communication may depend on the height of the container and / or the length of the channel. The timing of liquid communication may depend on the relative distance between the second end of the channel and the container.

於一些實施例中，各容器可具有本體849a,849b和蓋848a,848b。容器本體可為管狀。於一些實例中，容器本體可具有一圓柱狀部分。容器底部可為平坦、錐形、圓形或其任意組合。容器可具有一開放端和一封閉端。開放端可為容器之頂端，其可位於容器更接近一條或多條通道之一端。封閉端可為容器之底端，其可位於容器更遠離一條或多條通道之一端。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 In some embodiments, each container may have a body 849a, 849b and a lid 848a, 848b. The container body may be tubular. In some examples, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered, round, or any combination thereof. The container may have an open end and a closed end. The open end may be the top of the container, which may be located at one end of the container closer to one or more channels. The closed end may be the bottom end of the container, which may be located at one end of the container further away from one or more channels. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

支架830可具有一個或多個光學指示器，諸如光學窗口832a,832b。所述光學窗口可位於通道822a,822b之部分上。光學窗口可提供有關樣本是否已抵達和/ 或通過該光學窗口所顯示之通道部分的指示器。這可對評估樣本是否已充分流動，以便使用者將本體推入樣本採集裝置有用。於一些實例中，於通道與容器實現液體連通前，宜使樣本抵達通道第二端，或接近通道第二端。於一些實例中，樣本需於推入本體使得通道與容器形成液體連通前抵達通道之特定部分。所述通道之特定部分可位於光學窗口之下。 The bracket 830 may have one or more optical indicators, such as optical windows 832a, 832b. The optical window may be located on part of the channels 822a, 822b. The optical window can provide information about whether the sample has arrived and / or Or the indicator of the channel part displayed through the optical window. This may be useful for evaluating whether the sample has flowed sufficiently so that the user can push the body into the sample collection device. In some examples, before the channel and the container are in liquid communication, the sample should preferably reach the second end of the channel or be close to the second end of the channel. In some examples, the sample needs to reach a specific part of the channel before being pushed into the body so that the channel is in fluid communication with the container. The specific part of the channel may be located below the optical window.

基座840可具有一個或多個光學指示器，諸如光學窗口842a,842b。所述光學窗口可位於容器846a,846b上。於一些實例中，所述光學窗口可位於容器本體上。光學窗口可提供有關樣本是否已進入容器的指示器。光學窗口可顯示已有多少樣本填充容器。這可對評估是否已有足量之樣本進入容器有用。於一些實例中，於使容器與通道脫離液體連通前，宜使特定之量之樣本進入容器。容器中可需要具有預定體積之樣本，方可移除裝置基座，並由此使容器與通道脫離液體連通。 The base 840 may have one or more optical indicators, such as optical windows 842a, 842b. The optical window may be located on the container 846a, 846b. In some examples, the optical window may be located on the container body. The optical window can provide an indicator as to whether the sample has entered the container. The optical window shows how many samples have filled the container. This can be useful for assessing whether sufficient samples have entered the container. In some examples, it is desirable to allow a specific amount of sample to enter the container before disconnecting the container from the channel. A sample with a predetermined volume may be required in the container before the device base can be removed, and thereby the container and the channel are disconnected from liquid communication.

所述容器和/或與通道之介面可具有本文他處可所述之任意特徵或特性。於一些實例中，通道第二端可穿透容器蓋，由此使通道與容器形成液體連通。於一些實例中，通道可從容器中抽出，容器蓋可形成液體密封，由此於通道與容器脫離液體連通後，容器中實現液體密封環境。 The container and / or the interface with the channel may have any of the features or characteristics described elsewhere herein. In some examples, the second end of the channel can penetrate the container lid, thereby forming the channel and the container in liquid communication. In some examples, the channel can be withdrawn from the container, and the container lid can form a liquid seal, whereby a liquid-tight environment is achieved in the container after the channel is disconnected from the container in liquid communication.

可提供一個或多個配合組合。所述配合組合可包括通道支座和/或施力部件，如彈簧或彈性。所述支座 可將通道固定於本體上。所述支座可防止通道相對於本體滑動。所述支座可選地提供彈簧等施力部件可安置於其上之支架。 One or more combinations can be provided. The mating combination may include a channel support and / or a force-applying member, such as a spring or elasticity. The support The channel can be fixed on the body. The support can prevent the channel from sliding relative to the body. The support may optionally provide a bracket on which a biasing member such as a spring can be placed.

於一個實例中，所述配合組合可包括彈簧，其可施加作用力使得本體處於延伸狀態，而彈簧則處於其自然狀態。當本體處於其延伸狀態時，容器846a,846b與樣本本體820底部之間係提供有空間。通道第二端可處於不與容器內部液體連通之位置。 In one example, the mating combination may include a spring, which may exert a force so that the body is in an extended state, and the spring is in its natural state. When the body is in its extended state, a space is provided between the containers 846a, 846b and the bottom of the sample body 820. The second end of the channel may be in a position that is not in liquid communication with the interior of the container.

當本體被壓入時，彈簧852可被壓縮(亦請參考圖9A-9C)。通道第二端可穿透容器蓋。通道第二端可進入容器內部。於一些實例中，可提供一種力使液體被驅離通道，進入容器。舉例而言，可於通道第一及第二端之間產生壓降。可於通道第一端823a,823b施加正壓，和/或可於通道第二端施加負壓。所述正壓可相對於通道第二端和/或環境大氣為正。所述負壓可相對於通道第一端和/或環境大氣為負。於一個實例中，容器846a和846b其中可各具有真空。當通道第二端穿透容器時，容器中之負壓可將樣本吸入容器中。於替代實施例中，樣本可籍由毛細管力、重力或任意其它動力推動進入容器中。可選地，可有單個或多個動力組合向容器中加入液體。 When the body is pressed in, the spring 852 can be compressed (please also refer to FIGS. 9A-9C). The second end of the channel can penetrate the container lid. The second end of the channel can enter the interior of the container. In some examples, a force may be provided to drive the liquid away from the channel and into the container. For example, a pressure drop can be generated between the first and second ends of the channel. A positive pressure may be applied to the first end 823a, 823b of the channel, and / or a negative pressure may be applied to the second end of the channel. The positive pressure may be positive relative to the second end of the channel and / or the ambient atmosphere. The negative pressure may be negative relative to the first end of the channel and / or the ambient atmosphere. In one example, the containers 846a and 846b may each have a vacuum. When the second end of the channel penetrates the container, the negative pressure in the container can draw the sample into the container. In alternative embodiments, the sample may be pushed into the container by capillary force, gravity, or any other power. Alternatively, there may be a single or multiple power combinations to add liquid to the container.

於一些實例中，可採用不同類型之動力抽吸樣本進入通道，並從通道進入容器。舉例而言，毛細管力可將樣本抽入通道中，而壓降可推動樣本離開通道，進入容器。可採用任意動力組合抽吸樣本入通道及容器中。 In some examples, different types of power may be used to draw the sample into the channel and enter the container from the channel. For example, capillary force can draw the sample into the channel, and the pressure drop can push the sample out of the channel and into the container. Any power combination can be used to draw the sample into the channel and container.

當樣本被引入通道並沿通道長度移動後，可能已過了一段時間。使用者可將樣本引入樣本採集裝置，並等待樣本沿通道長度移動。可提供一個或多個沿通道長度佈置之光學指示器，其可指示樣本是否抵達通道末端。於其他實施例中，使用者可等待預定時間，然後推入本體。當使用者判定樣本業已移動了足夠的通道長度和/或自引入樣本以來已過了充分長的時間，所述本體即可被推入。所述本體可具有平坦表面，以方便使用者推動。於一些實例中，該平台表面可具有足以讓使用者手指壓在本體上的剖面面積。所述本體被推入後，可使通道與容器形成液體連通，且樣本可從通道流入容器中。可提供光學指示器，以便使用者可了解容器何時被填滿。 When the sample is introduced into the channel and moved along the length of the channel, it may have been a while. The user can introduce the sample into the sample collection device and wait for the sample to move along the length of the channel. One or more optical indicators can be provided along the length of the channel, which can indicate whether the sample has reached the end of the channel. In other embodiments, the user can wait for a predetermined time before pushing into the body. When the user determines that the sample has moved a sufficient channel length and / or a sufficient time has passed since the sample was introduced, the body can be pushed in. The body may have a flat surface to facilitate the user to push. In some examples, the surface of the platform may have a cross-sectional area sufficient for the user's finger to press on the body. After the body is pushed in, the channel and the container can be in liquid communication, and the sample can flow from the channel into the container. An optical indicator can be provided so that the user can know when the container is filled.

容器被裝滿後，即可採用本文他處所述之系統及方法轉運至所需地點。如前所述，可轉運整個樣本採集裝置。於其他實施例中，基座部分可與裝置其他部分分開。於一個實例中，基座可從樣本採集裝置上移除，且容器可與基座同時轉運。或者，基座可從樣本採集裝置上移除，以便提供至容器之通路，而容器即可從裝置上移除，隨後發運。 Once the container is filled, it can be transferred to the desired location using the systems and methods described elsewhere herein. As mentioned earlier, the entire sample collection device can be transported. In other embodiments, the base portion may be separate from the rest of the device. In one example, the base can be removed from the sample collection device, and the container can be transported simultaneously with the base. Alternatively, the base can be removed from the sample collection device to provide access to the container, and the container can be removed from the device before shipping.

現請參考圖9A-9C，現將說明樣本採集裝置900及使用方法之實例。於一個非限制性實例中，所述裝置可包括本體920、支架930及基座940。本體920、支架930及基座940可為彼此可移動。於一些實例中，所述裝置之不同部件可於不同使用階段為可移動。使用階段之實 例可包括當裝置處於延伸狀態、壓縮狀態及分離狀態時。 Referring now to FIGS. 9A-9C, an example of a sample collection device 900 and method of use will now be described. In one non-limiting example, the device may include a body 920, a bracket 930, and a base 940. The body 920, the bracket 930, and the base 940 may be movable to each other. In some examples, different components of the device may be movable at different stages of use. Use phase Examples may include when the device is in an extended state, a compressed state, and a separated state.

圖9A繪示處於延伸狀態的裝置900之實例。本體920可相對於支架延伸。被配置為運送樣本之通道922a,922b可被固定於所述本體。通道第一端可自本體和/或樣本採集裝置延伸而出。通道第二端可位於樣本採集裝置內和/或被其一部分包含。通道可與基座940所容納之各容器液體隔離。支架930可位於本體與基座之間。所述支架可至少部分包含通道之一部分。於一些實例中，支架可包含通道第二端。 FIG. 9A shows an example of the device 900 in the extended state. The body 920 may extend relative to the bracket. The channels 922a, 922b configured to transport samples may be fixed to the body. The first end of the channel can extend from the body and / or the sample collection device. The second end of the channel may be located within the sample collection device and / or contained by a portion thereof. The channel may be liquid-isolated from each container contained in the base 940. The bracket 930 may be located between the body and the base. The bracket may at least partially include a portion of the channel. In some examples, the stent may include the second end of the channel.

當處於延伸狀態時，所述裝置可具有延伸長度。裝置長度可為自基座底至通道第一端。或者，裝置長度可自基座底至本體頂加以量測。 When in the extended state, the device may have an extended length. The length of the device can be from the bottom of the base to the first end of the channel. Alternatively, the length of the device can be measured from the bottom of the base to the top of the body.

如圖9A所示，當樣本被引入裝置中時，裝置900可處於延伸狀態。舉例而言，樣本可被至少通道第一端接觸。可透過毛細管作用或本文所述之任意其它技術或動力將樣本抽入通道。單個或組合力可用於將樣本抽入裝置中。當樣本通過通道之時，裝置900可保持於延伸狀態。樣本可填滿通道之完整長度、通道長度之一部分或至少達成所需樣本採集體積之最小部分。 As shown in FIG. 9A, when a sample is introduced into the device, the device 900 may be in an extended state. For example, the sample may be contacted by at least the first end of the channel. The sample can be drawn into the channel by capillary action or any other technique or power described herein. Single or combined forces can be used to draw the sample into the device. As the sample passes through the channel, the device 900 can be maintained in an extended state. The sample can fill the full length of the channel, a portion of the channel length, or at least the smallest portion that achieves the required sample collection volume.

圖9B繪示處於壓縮狀態之裝置900的實例。本體920可相對於支架被壓縮。通道922a,922b可被固定於本體。所述通道可與其各自容器液體連通。當裝置進入壓縮狀態時，第一通道可與第一容器之內部形成液體連通，且第二通道可與第二容器之內部形成液體連通。 9B shows an example of the device 900 in a compressed state. The body 920 may be compressed relative to the bracket. The channels 922a, 922b may be fixed to the body. The channels can be in liquid communication with their respective containers. When the device enters a compressed state, the first channel may be in liquid communication with the interior of the first container, and the second channel may be in liquid communication with the interior of the second container.

作為非限制性實例，使用者可把本體920推向支架930(或反之)以使裝置進入壓縮狀態。部件之間之相對移動可包括兩個部件之移動。可選地，移動可包括僅移動其中之一。在本實例中，本體920可被一直推至支架930，以致無本體內部部分被暴露和/或本體之唇狀結構接觸支架。可使用當裝置被完全壓縮時可被接合的任意阻擋機制。或者，本體可僅被部分推動。舉例而言，本體內部部分之一部分可被暴露。支架可位於本體與基座之間。所述支架可至少部分包含通道之一部分。於一些實例中，通道第二端可延伸超出裝置支架。 As a non-limiting example, the user may push the body 920 toward the bracket 930 (or vice versa) to put the device into a compressed state. The relative movement between the components may include the movement of the two components. Alternatively, moving may include moving only one of them. In this example, the body 920 may be pushed all the way to the stent 930, so that no internal parts of the body are exposed and / or the lip structure of the body contacts the stent. Any blocking mechanism that can be engaged when the device is fully compressed can be used. Alternatively, the body may only be partially pushed. For example, a part of the internal part of the body may be exposed. The bracket may be located between the body and the base. The bracket may at least partially include a portion of the channel. In some examples, the second end of the channel may extend beyond the device support.

當處於壓縮狀態時，應暸解，裝置900可具有壓縮長度。裝置900之長度可為自基座底至通道第一端。或者，裝置長度可自基座底至本體頂加以量測。裝置壓縮長度可小於裝置延伸長度。於一些實施例中，裝置壓縮長度可為小於裝置延伸長度至少約0.1cm、0.5cm、1.0cm、1.5cm、2.0cm、2.5cm、3.0cm、3.5cm、4.0cm或5.0。裝置壓縮長度可小於或等於約50%、60%、70%、75%、80%、85%、90%、95%、97%或99%的裝置延伸長度。 When in a compressed state, it should be understood that the device 900 may have a compressed length. The length of the device 900 may be from the bottom of the base to the first end of the channel. Alternatively, the length of the device can be measured from the bottom of the base to the top of the body. The compressed length of the device may be less than the extended length of the device. In some embodiments, the compressed length of the device may be at least about 0.1 cm, 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 2.5 cm, 3.0 cm, 3.5 cm, 4.0 cm, or 5.0 less than the extended length of the device. The device compression length may be less than or equal to about 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 97%, or 99% of the device extension length.

可與裝置900一起提供一個或多個配合組合。所述配合組合可包括通道支座950和/或施力部件，如彈簧952或彈性。所述支座950可將轉接通道954保持固定於支架上。正如本文他處所述，轉接通道954可與採集通道一體形成或可為獨立件、採集通道一部分，或容器一部分之 單獨元件。於一個實施例中，所述支座950可防止轉接通道954相對於支架滑動。所述支座950可選地提供彈簧等施力部件可安置於其上之支架。當所述裝置處於壓縮狀態時，彈簧等該施力部件可處於壓縮狀態。當所述裝置處於壓縮狀態時，彈簧可施加一個力於裝置本體之上。 One or more mating combinations may be provided with the device 900. The mating combination may include a channel support 950 and / or a force-applying member, such as a spring 952 or elasticity. The support 950 can keep the adapter channel 954 fixed on the bracket. As described elsewhere herein, the transition channel 954 may be integral with the collection channel or may be a separate piece, part of the collection channel, or part of the container Separate components. In one embodiment, the support 950 can prevent the adapter channel 954 from sliding relative to the bracket. The support 950 may optionally provide a bracket on which a biasing member such as a spring can be placed. When the device is in a compressed state, the urging member such as a spring may be in a compressed state. When the device is in a compressed state, the spring can exert a force on the device body.

當樣本自通道被傳遞至各容器中時，裝置可處於壓縮狀態。於一些實例中，可籍由通道與容器內部形成液體連通時之間的壓降實現此傳遞。舉例而言，通道第二端可與容器內部形成液體連通。容器中可具有真空和/或負壓。當通道與真空容器形成液體連通時，樣本即可被吸入容器中。裝置於樣本被傳遞至容器之同時保持於壓縮狀態。樣本可填滿整個容器或容器之一部分。來自通道之樣本整體(和/或大於90%、95%、97%、98%、99%、99.5%或99.9%的樣本)可被傳遞至容器。或者，來自通道之樣本僅有一部分被傳遞至容器。 When the sample is transferred from the channel to each container, the device may be in a compressed state. In some instances, this transfer can be achieved by the pressure drop between the channel and the interior of the container when liquid communication is formed. For example, the second end of the channel may be in liquid communication with the interior of the container. The container may have vacuum and / or negative pressure. When the channel is in liquid communication with the vacuum container, the sample can be drawn into the container. The device is kept in a compressed state while the sample is transferred to the container. The sample can fill the entire container or part of the container. The entire sample from the channel (and / or samples greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9%) can be delivered to the container. Alternatively, only a portion of the sample from the channel is transferred to the container.

現請參考圖9C，現將說明處於分離狀態之樣本採集裝置900的實例。基座940可與裝置900其他部分分開。本體920可相對於支架930被延伸或壓縮。於一個實例中，延伸狀態可為自然狀態，以致當使用者不再施加力於本體之上時，本體可延伸回該延伸狀態。通道922a,922b可被固定於本體。 Referring now to FIG. 9C, an example of the sample collection device 900 in a separated state will now be described. The base 940 may be separated from other parts of the device 900. The body 920 may be extended or compressed relative to the bracket 930. In one example, the extended state may be a natural state, so that when the user no longer applies a force on the body, the body may extend back to the extended state. The channels 922a, 922b may be fixed to the body.

當裝置900處於分離狀態時，基座940可與裝置支架930分開。通道922a,922b可與其各自容器946a,946b脫離液體連通。當裝置900進入分離狀態時，第一通 道可與第一容器之內部脫離液體連通，且第二通道可與第二容器之內部脫離液體連通。這可依序或同時發生。當通道從容器移除時，容器可進入密封狀態，以防止不需要之材料進入容器。於一些實施例中，於通道移除後，容器可為液體密封。 When the device 900 is in a separated state, the base 940 may be separated from the device holder 930. The channels 922a, 922b may be out of liquid communication with their respective containers 946a, 946b. When the device 900 enters the separated state, the first pass The channel may be in liquid communication with the interior of the first container, and the second channel may be in liquid communication with the interior of the second container. This can happen sequentially or simultaneously. When the channel is removed from the container, the container can enter a sealed state to prevent unwanted materials from entering the container. In some embodiments, after the channel is removed, the container may be liquid-tight.

使用者可從支架930上移除基座940，使裝置進入分離狀態，由此移除其中之容器。於一些實施例中，基座可從支架上分開或反之。將基座從支架上分開可暴露由基座支持之容器946a,946b。容器可透過壓入配合或其它方式固定於基座中。容器946a,946b可為從基座可移除。作為非限制性實例，移除容器946a,946b使其可與其他容器一起被置於環境控制容器中，以運送至接收地點，諸如但不限於分析地點。可選地，可移除容器946a,946b，以便於發送至諸如但不限於分析地點等接收地點進行處理前，執行前處理，諸如但不限於離心分離。或者，容器946a,946b可保持與基座一起。 The user can remove the base 940 from the stand 930 to put the device into a separated state, thereby removing the container therein. In some embodiments, the base can be separated from the stand or vice versa. Separating the base from the stand exposes the containers 946a, 946b supported by the base. The container can be fixed in the base by press-fitting or other means. The containers 946a, 946b may be removable from the base. As a non-limiting example, the containers 946a, 946b are removed so that they can be placed in an environmentally controlled container along with other containers for shipping to a receiving location, such as but not limited to an analysis location. Optionally, the containers 946a, 946b may be removed to facilitate sending to a receiving location such as, but not limited to, an analysis location, for pre-processing, such as but not limited to centrifugal separation. Alternatively, the containers 946a, 946b may remain with the base.

圖10A-10B係處於分離狀態之樣本採集裝置1000的更多視圖。當處於分離狀態時，基座1040可與裝置支架1030和/或本體1020(部分或全部)分開。籍此，容器1046a和1046b即可透過當裝置1000不處於分離狀態時未曾外露之基座1040末端移除。 10A-10B are more views of the sample collection device 1000 in a separated state. When in a separated state, the base 1040 may be separated (partially or fully) from the device holder 1030 and / or the body 1020. Accordingly, the containers 1046a and 1046b can be removed through the end of the base 1040 that was not exposed when the device 1000 was not in the separated state.

當所述裝置處於分離狀態時，一條或多條通道1022a,1022b可與基座1040所容納之一個或多個容器1046a,1046b液體隔離。所述容器可液體性密封於其環 境。容器中可包含樣本，該樣本透過採集通道運送，達到最低填充程度，且隨後依序儲存於各自容器中。基座1040可包括一個或多個光學指示器1046a,1046b。所述光學指示器可顯示其中容器之一部分，如此，於容器中最低填充程度達到前，裝置1000將不會進入分離狀態。作為非限制性實例，容器可具有一種光透射材料，其可允許使用者自基座外觀察容器中的樣本。 When the device is in a separated state, one or more channels 1022a, 1022b may be fluidly isolated from one or more containers 1046a, 1046b contained in the base 1040. The container can be liquid tightly sealed to its ring territory. The container may contain a sample, which is transported through the collection channel to a minimum filling level, and then sequentially stored in the respective containers. The base 1040 may include one or more optical indicators 1046a, 1046b. The optical indicator can display a part of the container, so that the device 1000 will not enter the separated state until the minimum filling level in the container is reached. As a non-limiting example, the container may have a light-transmitting material that may allow the user to view the sample in the container from outside the base.

於一些實施例中，基座1040可包含容器之至少一部分。基座可具有中空內部及圍繞該中空內部之壁。基座可具有可支持容器之一種或多種有形特徵。容器可被設置於所述中空內部。所述壁可圍繞容器。基座可具有一開放式頂端，容器可透過該頂端暴露。容器可能或可能不透過所述開放式頂端被移除。 In some embodiments, the base 1040 may include at least a portion of the container. The base may have a hollow interior and a wall surrounding the hollow interior. The base may have one or more tangible features that can support the container. The container may be provided inside the hollow. The wall may surround the container. The base can have an open top through which the container can be exposed. The container may or may not be removed through the open top.

具有多條採集通道之採集裝置Acquisition device with multiple acquisition channels

現請參考圖11A-11F，現將說明本文所述又一實施例。此實施例提供體液樣本採集裝置1100，用於採集可匯集或以其它方式形成於表面之液體樣本，所述表面為諸如但不限於對象之皮膚或其他目標區域。儘管此實施例繪示限定至少兩條其中具有不同體積之採集通道的裝置本體，惟應暸解，具有更少或更多數目採集通道之裝置並未被排除。亦不排除一條或多條通道具有相同採集體積之實施例。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 Referring now to FIGS. 11A-11F, another embodiment described herein will now be described. This embodiment provides a body fluid sample collection device 1100 for collecting liquid samples that can be collected or otherwise formed on a surface, such as but not limited to a subject's skin or other target area. Although this embodiment illustrates a device body that defines at least two collection channels with different volumes, it should be understood that devices with a smaller or greater number of collection channels are not excluded. It also does not exclude embodiments in which one or more channels have the same acquisition volume. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

圖11A繪示體液樣本採集裝置1100之實施例的 透視圖，其具有配置為接觸位於一表面上之液體樣本的遠端1102。於此實施例中，遠端1102可具有設計用於更佳地接觸形成於一表面上之體液或樣本微滴或團之配置。除所需形狀外，一些實施例亦可於遠端1102進行表面處理，諸如但不限於化學處理、織構化、表面特徵或塗層，以促進朝向遠端1102之一個或多個開口1104及1106之液體流動，進而引至裝置1100中的通道。 FIG. 11A illustrates an embodiment of a body fluid sample collection device 1100 A perspective view with a distal end 1102 configured to contact a liquid sample on a surface. In this embodiment, the distal end 1102 may have a configuration designed to better contact body fluid or sample droplets or masses formed on a surface. In addition to the desired shape, some embodiments may also perform surface treatments on the distal end 1102, such as but not limited to chemical treatments, texturing, surface features, or coatings, to promote one or more openings 1104 toward the distal end 1102 and The liquid of 1106 flows and leads to the channel in the device 1100.

如圖11A所示，此樣本採集裝置1100實施例具有兩個開口1104和1106用於接收樣本液體。應暸解，一些實施例中，遠端上可具有兩個以上的開口。一些實施例於遠端上可僅具有一個開口。可選地，一些實施例可沿離開裝置1100之遠端1102的側面或其他表面設有額外開口。開口1104和1106可具有任意剖面形狀。於一些非限制性實例中，開口可具有圓形、橢圓形、三角形、四邊形(如正方形、長方形、梯形)、五邊形、六邊形、八邊形或任意其它剖面形狀。此剖面形狀沿採集裝置本體長度可保持不變或可變化。於一些實例中，開口可具有小於或等於約2mm²、1.5mm²、1mm²、0.8mm²、0.5mm²、0.3mm²或0.1mm²之剖面面積。一些實施例係具有相同形狀之開口。其它則為一個或多個開口採用不同形狀。 As shown in FIG. 11A, this embodiment of the sample collection device 1100 has two openings 1104 and 1106 for receiving sample liquid. It should be appreciated that in some embodiments, there may be more than two openings on the distal end. Some embodiments may have only one opening on the distal end. Optionally, some embodiments may provide additional openings along the side or other surface away from the distal end 1102 of the device 1100. The openings 1104 and 1106 may have any cross-sectional shape. In some non-limiting examples, the opening may have a circular shape, an elliptical shape, a triangular shape, a quadrangular shape (eg, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other cross-sectional shape. The cross-sectional shape can be kept constant or variable along the length of the collecting device body. In some examples, the opening may have a cross-sectional area of less than or equal to about 2 mm ² , 1.5 mm ² , 1 mm ² , 0.8 mm ² , 0.5 mm ² , 0.3 mm ² or 0.1 mm ² . Some embodiments have openings of the same shape. Others use different shapes for one or more openings.

可為樣本採集裝置1100之本體的樣本填充部分1120可用透明和/或半透明材料製成，以便使用者能夠觀察樣本是否已進入樣本填充部分1120中的樣本採集通道(參考圖11B)。於一些實施例中，整個樣本填充部分 1120為透明或半透明。或者，於一些實施例中，僅有通道上部之所有區域或僅有通道或樣本填充部分1120之選定部分為透明或半透明，以便使用者運用視覺觀察樣本填充入樣本填充部分1120中。可選地，所述樣本填充部分用不透明材料製成，惟具有開口或窗口以使其中填充程度可視。裝置1100亦可包括一個或多個觀察窗口1112和1114，以便使用者觀察何時抵達所需填充程度。所述觀察窗口可用透明和/或半透明材料製成。或者，所述觀察窗口可為其中無任何材料之開口。亦可採用額外的觀察窗口以判定，是否採集通道中的全部液體已被排空進入容器1146a和1146b(參考圖11B)。 The sample filling portion 1120 of the body of the sample collection device 1100 may be made of a transparent and / or translucent material so that the user can observe whether the sample has entered the sample collection channel in the sample filling portion 1120 (refer to FIG. 11B). In some embodiments, the entire sample fills part 1120 is transparent or translucent. Alternatively, in some embodiments, only all areas of the upper part of the channel or only selected parts of the channel or the sample filling portion 1120 are transparent or semi-transparent, so that the user can visually observe the sample filling into the sample filling portion 1120. Optionally, the sample filling part is made of an opaque material, but has an opening or a window to make the filling degree visible. The device 1100 may also include one or more viewing windows 1112 and 1114 for the user to observe when the desired filling level is reached. The observation window may be made of transparent and / or translucent material. Alternatively, the observation window may be an opening without any material therein. An additional observation window can also be used to determine whether all the liquid in the collection channel has been emptied into the containers 1146a and 1146b (refer to FIG. 11B).

圖11A另係繪示支架1130之一些實施例可具有光學窗口1132及1134，其佈置用於顯示容器1146a及1146b中的填充程度，以說明基座1140中的所述容器是否已被移至接收樣本液體的位置。可選地，窗口1132及1134可為用作按扣特徵導向之凹陷，以便限定活動中的起始及終止位置。應暸解，基座可被配置為容納一個或多個樣本容器。作為非限制性實例，整個基座1140可於填滿樣本前或後從樣本採集裝置上移除。基座1140可被用作支座，以便於運送過程中固定其中之樣本容器，且於此類實施例中，基座1140以及樣本容器會被載入運輸托盤或其他支座以便運送。或者，一些實施例可將樣本容器從基座1140上移除，進而運送容器，而不用基座1140容納所述容器。 FIG. 11A also shows that some embodiments of the stand 1130 may have optical windows 1132 and 1134, which are arranged to show the filling level in the containers 1146a and 1146b to illustrate whether the container in the base 1140 has been moved to the receiving The location of the sample liquid. Alternatively, the windows 1132 and 1134 can be recesses that serve as guides for snap features to define the starting and ending positions in the event. It should be appreciated that the base may be configured to accommodate one or more sample containers. As a non-limiting example, the entire base 1140 can be removed from the sample collection device before or after the sample is filled. The base 1140 can be used as a support for fixing the sample container therein during transportation, and in such embodiments, the base 1140 and the sample container are loaded into a transport tray or other support for transportation. Alternatively, some embodiments may remove the sample container from the base 1140 and then transport the container without the base 1140 containing the container.

圖11B繪示沿圖11C所示實施例之剖面線B-B的剖視圖。圖11B繪示部分1120中的通道1126和1128。樣本填充部分1120可由兩片或更多片相連接以限定所述部分1120之部件形成。一些實施例可於一個部件上限定通道，隨後採用與第一片相配之另一片限定通道之相對或頂壁表面。就製造而言，這使得通道於某一片上模塑形成，或形成於本體中，而相對片將與之相配作為通道蓋或亦可包括通道之部分。通道1126及1128可僅於部分1120中形成，或亦可延伸入支架1130，其具有與容納於基座或載體1140連接之特徵。一些實施例可與部分1120及1130一體形成。支架1130亦可被配置為固定轉接通道1150，其將使通道1126和1128與其各自容器1146a及1146b形成液體連接。 FIG. 11B is a cross-sectional view taken along section line B-B of the embodiment shown in FIG. 11C. FIG. 11B illustrates the channels 1126 and 1128 in the portion 1120. The sample filling portion 1120 may be formed by two or more pieces connected to define parts of the portion 1120. Some embodiments may define a channel on one component, and then use another piece that matches the first sheet to define the opposing or top wall surface of the channel. In terms of manufacturing, this allows the channel to be molded on a certain piece or formed in the body, and the opposing piece will be matched with it as a channel cover or may also include part of the channel. The channels 1126 and 1128 may be formed only in the portion 1120, or may extend into the bracket 1130, which has the feature of being connected to the base or carrier 1140. Some embodiments may be integrally formed with portions 1120 and 1130. The bracket 1130 may also be configured as a fixed adapter channel 1150, which will allow the channels 1126 and 1128 to form a liquid connection with their respective containers 1146a and 1146b.

儘管本文所述這些實施例採用兩條通道及兩個容器，惟應暸解，並不排除其他數目之通道及容器。一些實施例可具有多於容器之通道，其中一些通道將與同一容器耦合。一些實施例可具有多於通道之容器，其中多個容器可***作地與同一通道耦合。 Although the embodiments described herein use two channels and two containers, it should be understood that other numbers of channels and containers are not excluded. Some embodiments may have more channels than containers, some of which will be coupled to the same container. Some embodiments may have more containers than channels, where multiple containers may be operatively coupled to the same channel.

如圖11B所示，通道1126及1128可為不同尺寸。由此各通道可採集不同液體體積，隨後其同時被傳遞至容器1146a及1146b。可選地，一些實施例可具有容納相同體積液體之通道1126及1128。於一些實施例中，通道1126及1128之液體路徑之形狀和/或角度使得接近遠端1102之開口較之近端彼此更近，其可分得更開，已安排進 入容器1146a及1146b。對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 As shown in FIG. 11B, the channels 1126 and 1128 can be of different sizes. Thus each channel can collect different liquid volumes, which are then transferred to the containers 1146a and 1146b at the same time. Alternatively, some embodiments may have channels 1126 and 1128 that contain the same volume of liquid. In some embodiments, the shapes and / or angles of the liquid paths of channels 1126 and 1128 are such that the openings near the distal end 1102 are closer to each other than the proximal end, they can be divided further apart, and have been arranged into Into containers 1146a and 1146b. Changes or substitutions are made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

圖11B亦繪示一些實施例可將針頭用於本體1130中的轉接通道1150及1152，其與通道1126及1128相通。所述針頭各自具有一條通道，使得液體可自採集通道1126及1128從其中通過至針頭末端。如圖11B所示，基座1140中的容器1146a及1146b相對於支架1130可滑動，如箭頭1156指示。支架1130與基座1140之間的相對運動可關閉間隙1154。關閉間隙1154使得轉接通道1150進入容器1146a之蓋1148a，直至容器1146a之內部與採集通道1126形成液體連通。此刻，結構中動力即推動通道1126中的液體進入容器1146a。 FIG. 11B also illustrates that some embodiments may use needles for the transition channels 1150 and 1152 in the body 1130, which are in communication with the channels 1126 and 1128. The needles each have a channel so that liquid can pass from the collection channels 1126 and 1128 to the end of the needle. As shown in FIG. 11B, the containers 1146a and 1146b in the base 1140 are slidable relative to the bracket 1130, as indicated by arrow 1156. The relative movement between the bracket 1130 and the base 1140 can close the gap 1154. Closing the gap 1154 allows the transition channel 1150 to enter the cover 1148a of the container 1146a until the interior of the container 1146a is in liquid communication with the collection channel 1126. At this moment, the power in the structure pushes the liquid in the channel 1126 into the container 1146a.

作為非限制性實例，可採用任意動力組合抽吸樣本入容器中。一些實施例可運用容器1146a中的真空引力抽吸樣本入容器中。一些實施例可運用外部壓力導致之推力移動液體入容器中。一些實施例可同時運用這兩種。一些實施例可依賴毛細管力和/或重力。於一些實施例中，抽吸樣本入通道中之動力不同於抽吸樣本入容器中之動力。於一些替代實施例中，各階段可採用相同之動力。於一些實施例中，依序或於限定時間施加動力。作為非限制性實例，直至至少一條通道已達到最低填充程度時，方才施加抽吸樣本入容器中之動力。可選地，直至至少兩條通道均已達到各自最低填充程度時，方才施加抽吸樣本入容器中之動力。可選地，直至所有通道均已達到各自最低 填充程度時，方才施加抽吸樣本入容器中之動力。於一些實施例中，同時施加所述動力。此項所引用特徵可適用於本文所述任意實施例。 As a non-limiting example, any combination of power may be used to draw the sample into the container. Some embodiments may use the vacuum in the container 1146a to draw the sample into the container. Some embodiments may use the thrust caused by external pressure to move the liquid into the container. Some embodiments may use both. Some embodiments may rely on capillary force and / or gravity. In some embodiments, the power to draw the sample into the channel is different from the power to draw the sample into the container. In some alternative embodiments, the same power may be used in each stage. In some embodiments, the power is applied sequentially or at a defined time. As a non-limiting example, the motivation to draw the sample into the container is not applied until at least one channel has reached the minimum filling level. Optionally, the motive force for drawing the sample into the container is not applied until at least two channels have reached their respective minimum filling levels. Optionally, until all channels have reached their minimum At the filling level, the motivation to draw the sample into the container is applied. In some embodiments, the power is applied simultaneously. The features cited in this item can be applied to any of the embodiments described herein.

現請參考圖11E，其繪示裝置1100之放大剖視圖。此實施例顯示，支架1130具有唇狀部分1136，其尺寸為延伸超越轉接通道1150及1152且足以防止使用者將手指***間隙1154並因此被針頭之一扎到手指。 Please refer to FIG. 11E, which shows an enlarged cross-sectional view of the device 1100. This embodiment shows that the bracket 1130 has a lip-shaped portion 1136 that is dimensioned to extend beyond the adapter channels 1150 and 1152 and is sufficient to prevent the user from inserting a finger into the gap 1154 and thus being pinched by one of the needles.

另如圖11B及11E所示，本實施例於樣本採集裝置1100中具有至少兩條通道。這使得通道1128及1126可各自向樣本中引入一種不同材料。作為非限制性實例，如樣本為全血，一條通道可向血液中引入肝磷脂，同時另一條通道則引入乙二胺四乙酸(EDTA)。這些抗凝劑不僅防止通道於填充過程中發生過早凝固，而且還將抗凝劑引入全血中，由此為處於容器1146a及1146b中進行轉運作準備。可選地，除所述抗凝劑外或代替所述抗凝劑，所述通道亦可塗覆有血漿。血漿塗層可減少通道中體液樣本之流動阻力。此類塗層可與通道中將使用之任意其他塗層一起，以諸如但不限於條狀、環狀或其它圖案等圖案加以應用。 11B and 11E, this embodiment has at least two channels in the sample collection device 1100. This allows channels 1128 and 1126 to each introduce a different material into the sample. As a non-limiting example, if the sample is whole blood, one channel can introduce heparin into the blood, while the other channel introduces ethylenediaminetetraacetic acid (EDTA). These anticoagulants not only prevent premature coagulation of the channel during filling, but also introduce anticoagulants into the whole blood, thereby preparing for the transfer operation in the containers 1146a and 1146b. Optionally, in addition to or instead of the anticoagulant, the channel may also be coated with plasma. The plasma coating can reduce the flow resistance of the body fluid sample in the channel. Such coatings can be applied in patterns such as, but not limited to, strips, rings, or other patterns along with any other coatings to be used in the channels.

可選地，各通道中具有足量之抗凝劑，使得樣本液體僅需通過通道一次，即可含有所需程度之抗凝劑。於傳統血液小瓶中，血樣於進入小瓶前不包含抗凝劑，一旦處於小瓶中，技師通常反復地傾斜、搖晃和/或攪拌小瓶，以混合小瓶中的抗凝劑。於本實施例中，樣本液體將 於進入樣本容器前即含有抗凝劑，且其毋須反復地傾斜或攪拌樣本採集裝置即可實現。於本文實施例中，一次通過即提供充足時間向樣本液體中加入抗凝劑等添加物，並達到充分濃度。於一個實施例中，一條EDTA通道塗覆有200mg/mL EDTA，體積為54uL；肝磷脂通道塗覆有250單位/mL肝磷脂，體積約為22uL。於另一個實施例中，EDTA通道塗覆有300mg/mL EDTA，體積為70uL；肝磷脂通道塗覆有250單位/mL肝磷脂，體積約為30uL。作為非限制性實例，體積為50至70uL的通道可塗覆有約200至300mg/mL EDTA範圍內的EDTA。可選地，體積為70至100uL的通道可塗覆有約300至450mg/mL EDTA範圍內的EDTA。可選地，體積為20至30uL的通道可塗覆有250單位/mL肝磷脂以上範圍內的肝磷脂。作為實例，所述材料可為溶液，以不足1小時時間塗覆至目標表面，隨後過夜乾燥。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 Optionally, each channel has a sufficient amount of anticoagulant, so that the sample liquid only needs to pass through the channel once to contain the desired degree of anticoagulant. In traditional blood vials, the blood sample contains no anticoagulant before entering the vial. Once in the vial, the technician usually repeatedly tilts, shakes, and / or stirs the vial to mix the anticoagulant in the vial. In this embodiment, the sample liquid will The anticoagulant is contained before entering the sample container, and it can be achieved without repeatedly tilting or stirring the sample collection device. In the examples herein, one pass provides sufficient time to add additives such as anticoagulants to the sample liquid and reach a sufficient concentration. In one embodiment, one EDTA channel is coated with 200 mg / mL EDTA in a volume of 54 uL; the heparin channel is coated with 250 units / mL heparin in a volume of approximately 22 uL. In another embodiment, the EDTA channel is coated with 300 mg / mL EDTA in a volume of 70 uL; the heparin channel is coated with 250 units / mL heparin in a volume of approximately 30 uL. As a non-limiting example, a channel with a volume of 50 to 70 uL may be coated with EDTA in the range of about 200 to 300 mg / mL EDTA. Alternatively, channels with a volume of 70 to 100 uL may be coated with EDTA in the range of about 300 to 450 mg / mL EDTA. Alternatively, channels with a volume of 20 to 30 uL may be coated with heparin in the range of 250 units / mL or more. As an example, the material may be a solution, applied to the target surface in less than 1 hour, and then dried overnight. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

現請參考圖11G，現將說明又一實施例。圖11G之實施例顯示，樣本採集裝置1200之遠端1202上，不再為各通道提供開口1204，代之以樣本採集裝置1200將兩條或更多條通道合併為單條通道。圖11G之實施例顯示一條共同通道部分，隨後該共同通道分成複數條單獨通道。如下圖11I所述，可選地，係設有反逆流裝置，諸如但不限於沿各通道設置之排氣口，以便於自通道向樣本容器填充和/或提取樣本過程中，減少從一條通道抽取樣本 進入另一條通道之可能性。 Referring now to FIG. 11G, another embodiment will now be described. The embodiment of FIG. 11G shows that the distal end 1202 of the sample collection device 1200 no longer provides openings 1204 for each channel. Instead, the sample collection device 1200 combines two or more channels into a single channel. The embodiment of FIG. 11G shows a common channel portion, and then the common channel is divided into a plurality of individual channels. As shown in FIG. 11I below, optionally, a reverse flow device is provided, such as but not limited to exhaust ports provided along each channel, so as to facilitate filling and / or sample extraction from the channel to the sample container, reducing the number of Take a sample Possibility to enter another channel.

如圖11H所示，共同流動路徑之運用可減少位於樣本採集裝置1200外部之開口數目，由此其可使開口1204接觸體液樣本。這亦可籍由於體液樣本進入採集裝置之同一通道上具有更多毛細管抽取，增強用於抽取體液樣本入樣本採集裝置1200中之毛細管力。 As shown in FIG. 11H, the use of the common flow path can reduce the number of openings located outside the sample collection device 1200, thereby allowing the opening 1204 to contact the body fluid sample. This can also be attributed to the fact that there are more capillary extractions on the same channel of the body fluid sample entering the collection device, which enhances the capillary force for drawing the body fluid sample into the sample collection device 1200.

現請參考圖11I，現將說明樣本採集裝置特選部件之剖視圖。圖11I顯示，所述樣本採集裝置可具有擁有通向裝置進口之共同段1186的兩條通道1182及1184。於一些實施例中，所述共同段1186就尺寸、形狀和/或定位而言為通道1182或1184之一的延續。可選地，所述共同段1186與通道1182、1184或可與所述共同段1186液體連通之任意其他通道中任一均不具有相同尺寸、形狀和/或定位。圖11I顯示，於一個非限制性實施例中，通道1182及1184之間介面1188處可設有一個台階。此介面1188可被配置為確保液體流入兩條通道中，以使其均實現完全填滿。於一個實施例中，此介面1188具有大於流離此介面1188之通道1182的尺寸。儘管未排除其他尺寸，具有較大尺寸之此介面1188可確保充足流量將進入通道1182，而於本實施例中，該通道相對於通道1184具有較小直徑和縮減之體積。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 Referring now to FIG. 11I, a cross-sectional view of selected components of the sample collection device will now be described. Figure 11I shows that the sample collection device may have two channels 1182 and 1184 with a common segment 1186 leading to the device inlet. In some embodiments, the common segment 1186 is a continuation of one of the channels 1182 or 1184 in terms of size, shape, and / or positioning. Optionally, none of the common segment 1186 and the channels 1182, 1184 or any other channel that can be in fluid communication with the common segment 1186 have the same size, shape, and / or positioning. FIG. 11I shows that in a non-limiting embodiment, a step may be provided at the interface 1188 between the channels 1182 and 1184. This interface 1188 can be configured to ensure that the liquid flows into the two channels so that they are completely filled. In one embodiment, the interface 1188 has a larger size than the channel 1182 flowing away from the interface 1188. Although other sizes are not excluded, this interface 1188 having a larger size can ensure that sufficient flow will enter the channel 1182, and in this embodiment, the channel has a smaller diameter and reduced volume relative to the channel 1184. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

圖11I亦顯示，係具有排氣口1190及1192，其可被用於防止通道間交叉流動，尤其是當樣本被傳遞至樣 本容器中時。於一個實施例中，所述排氣口1190及1192永遠打開。於另一個實施例中，排氣口1190及1192可僅於選定時間打開，諸如但不限於通道1182及1184被填滿或相當大程度地填滿後。一些實施例可使用一種可溶解材料堵塞所述排氣口1190及1192，直至其與樣本液體接觸。可選地，一些實施例可使用可滑動蓋覆蓋所述排氣口1190及1192之一或更多，籍此其僅於使用者選定時間打開。於一個實施例中，所述蓋與樣本容器相連，由此樣本容器進入與通道液體連通之移動亦將打開所述排氣口1190及1192之一或更多，從而減少通道間交叉流動之風險。可選地，亦可運用諸如但不限於閥門、閘或插塞等其他防交叉流動機制防止通道1190及1192之間的液體傳遞。 Figure 11I also shows that it has exhaust ports 1190 and 1192, which can be used to prevent cross-flow between channels, especially when the sample is transferred to the sample When in this container. In one embodiment, the exhaust ports 1190 and 1192 are always open. In another embodiment, the exhaust ports 1190 and 1192 may only be opened at a selected time, such as but not limited to after the channels 1182 and 1184 are filled or filled to a considerable extent. Some embodiments may use a soluble material to block the vents 1190 and 1192 until it comes into contact with the sample liquid. Alternatively, some embodiments may use a slidable cover to cover one or more of the exhaust ports 1190 and 1192, whereby it only opens at a time selected by the user. In one embodiment, the cover is connected to the sample container, so that the movement of the sample container into liquid communication with the channel will also open one or more of the exhaust ports 1190 and 1192, thereby reducing the risk of cross-flow between the channels . Alternatively, other anti-cross flow mechanisms such as but not limited to valves, gates, or plugs can also be used to prevent liquid transfer between channels 1190 and 1192.

圖11I亦顯示，係具有位於轉接器1150及1152上之防洩漏裝置1194。於本實施例中，防洩漏裝置1194為可從第一位置滑動至第二位置之熔塊，其於第一位置時防止樣本洩漏出轉接器1150及1152，於第二位置時其允許轉接器將液體送入樣本容器中。於一個非限制性實施例中，當防洩漏裝置1194被樣本容器或容納樣本容器之外殼結合時，其將滑動。此非限制性實施例中的樣本容器或外殼之移動顯示，這些部件之移動亦將導致防洩漏裝置1194之移動。 FIG. 11I also shows that it has a leakage prevention device 1194 on the adapters 1150 and 1152. In this embodiment, the anti-leakage device 1194 is a frit that can slide from the first position to the second position, which prevents the sample from leaking out of the adapters 1150 and 1152 in the first position, and allows it to rotate in the second position The connector sends the liquid into the sample container. In one non-limiting embodiment, when the leak prevention device 1194 is combined by the sample container or the housing containing the sample container, it will slide. The movement of the sample container or housing in this non-limiting embodiment shows that movement of these components will also cause movement of the leak prevention device 1194.

現請參考圖11J，現將說明樣本採集裝置1160之又一實施例。樣本採集裝置1160之此實施例顯示，裝置1160具有通往裝置1160中複數條通道1162及1164之樣本 進入位置1204。儘管圖11J顯示，通道1162及1164可具有不同形狀和/或尺寸，一些實施例可被配置為具有相同體積和/或形狀。還應暸解，樣本進入位置1204可位於裝置1160表面，或可選地，其可為自裝置1160本體延伸之尖端、噴嘴、短截或其它突出物的一部分。此突出物可與裝置本體處於同一平面或平行，或可選地，其可形成一角度，使得突出物軸線與裝置1160之平面交錯。 Referring now to FIG. 11J, another embodiment of the sample collection device 1160 will now be described. This embodiment of the sample collection device 1160 shows that the device 1160 has samples leading to a plurality of channels 1162 and 1164 in the device 1160 Enter position 1204. Although FIG. 11J shows that the channels 1162 and 1164 may have different shapes and / or sizes, some embodiments may be configured to have the same volume and / or shape. It should also be appreciated that the sample entry location 1204 can be on the surface of the device 1160, or alternatively, it can be part of a tip, nozzle, stub, or other protrusion extending from the body of the device 1160. This protrusion may be in the same plane or parallel to the device body, or alternatively, it may form an angle so that the protrusion axis intersects the plane of the device 1160.

圖11J進而顯示，於一些實施例中，可具有樣本流特徵1166及1168，以抽吸或另行優選引導樣本至所需方向。於一些實施例中，所述特徵1166及1168為實現減小通道於至少一個方向上之尺寸(諸如但不限於寬度或高度)的引導，並由此增強通過具有縮減尺寸之區域的毛細作用。於一個非限制性實施例中，於樣本進入通道過程中，此等流特徵1166及1168可協助通過接近防交叉流動特徵1170之通道區域的液體流。於一個實施例中，此等流特徵1166及1168之尺寸設定為，當流主要籍由毛細作用被抽吸時，優選改善輸入方向之流。於一種情景中，輸出流不基於毛細管力，而是基於真空吸力(如來自一條相鄰通道)，且本實施例中此等流特徵1166及1168未被配置為提供基於該等真空、非毛細管流條件下之幫助。流特徵1166及1168之部分，而不是全部實施例因而被配置為於至少一種類型流條件，而不是其他特定流條件下提供幫助。可選地，一些實施例可單獨運用其他技術或與諸如但不限於有形特徵、恐水材料、親水材料或其他技術等引導 之組合，以推/拉動樣本至所需位置。 FIG. 11J further shows that, in some embodiments, there may be sample flow features 1166 and 1168 to aspirate or otherwise preferentially guide the sample to the desired direction. In some embodiments, the features 1166 and 1168 are to achieve guidance to reduce the size of the channel in at least one direction (such as but not limited to width or height), and thereby enhance capillary action through areas with reduced dimensions. In a non-limiting embodiment, these flow features 1166 and 1168 can assist the flow of liquid through the channel region near the cross-flow prevention feature 1170 during sample entry into the channel. In one embodiment, the dimensions of these flow features 1166 and 1168 are set such that when the flow is primarily drawn by capillary action, the flow in the input direction is preferably improved. In one scenario, the output flow is not based on capillary force, but on vacuum suction (such as from an adjacent channel), and in this embodiment, these flow features 1166 and 1168 are not configured to provide vacuum-based, non-capillary Help under streaming conditions. Some, but not all of the embodiments of flow features 1166 and 1168 are therefore configured to provide assistance under at least one type of flow condition rather than other specific flow conditions. Alternatively, some embodiments may use other techniques alone or guide with techniques such as, but not limited to, tangible features, water-repellent materials, hydrophilic materials, or other techniques Combination to push / pull the sample to the desired position.

圖11J亦顯示，於本文一個或多個實施例中，可具有傾斜側壁特徵1167，其成圓錐形地或另行縮減通道剖面面積，此樣本運送方式可使被留置於通道中不被採集之樣本量減至最少。圖11J亦顯示，可具有定位特徵1169以促進於製造中，以限定位置及方位將各部件接合在一起。 FIG. 11J also shows that in one or more embodiments herein, it may have a sloping side wall feature 1167 that conically or otherwise reduces the channel cross-sectional area. This sample transport method allows samples that are left in the channel not to be collected The amount is minimized. FIG. 11J also shows that positioning features 1169 may be provided to facilitate manufacturing, to join the components together in a defined position and orientation.

圖11K繪示樣本採集裝置1160實施例之側視圖。裝置1160實施例之側視圖顯示，實施例中具有一個或多個防交叉流動特徵1170，諸如但不限於排氣口以將通道1162及1164之間的不利樣本交叉流動降至最低，尤其是當各通道中達到所需填充程度時。防交叉流動特徵1170及1172可防止因排氣口造成液體路徑間斷而導致之交叉流動。當支座1140中的容器被接合，且提供額外動力將樣本從通道吸入容器中時，交叉流動問題最為常見。此“吸引”效應可無意中將樣本從一條通道抽吸至相鄰通道中。為將交叉流動降至最低，與將樣本從通道吸入容器中相關之力將從排氣口抽吸，而不抽吸相鄰通道中的液體，由此將不利樣本混合減至最少。 11K shows a side view of an embodiment of a sample collection device 1160. A side view of an embodiment of the device 1160 shows that the embodiment has one or more cross-flow prevention features 1170, such as but not limited to vents to minimize adverse sample cross-flow between channels 1162 and 1164, especially when When the required filling level is reached in each channel. Cross-flow prevention features 1170 and 1172 can prevent cross-flow due to the interruption of the liquid path caused by the vent. Cross-flow problems are most common when the container in the holder 1140 is engaged and provides additional power to draw the sample from the channel into the container. This "attractive" effect can inadvertently draw samples from one channel into adjacent channels. To minimize cross-flow, the force associated with drawing the sample from the channel into the container will be drawn from the exhaust port without drawing liquid in the adjacent channel, thereby minimizing adverse sample mixing.

圖11K亦顯示，於一些實施例中，可具有共同部分1130及1140，其可適用於與不同樣本填充部分1120一起使用。一些實施例可使用不同毛細填充部分1120。一些實施例可採用運用不同類型擷取技術之填充部分，諸如但不限於靜脈抽血、動脈抽血所獲得之樣本或自對象內部 位置或目標位置抽取之其他樣本。 FIG. 11K also shows that in some embodiments, there may be common portions 1130 and 1140, which may be suitable for use with different sample filling portions 1120. Some embodiments may use different capillary filling portions 1120. Some embodiments may use filled portions using different types of extraction techniques, such as but not limited to samples obtained from venous blood draws, arterial blood draws, or from within the subject Other samples taken from the location or target location.

現請參考圖11L，其繪示樣本流特徵1166及1168之實施例。此具有通道1162及1164和接近共同進口路徑1165之樣本流特徵1166及1168的樣本採集部分剖視圖顯示，於一個實施例中，所述特徵需設於接近樣本進入通道之處。圖11L亦顯示，對於具有不同體積之通道，宜將進口1165設置於更接近具有較大體積之通道1164，如進口1165之非對稱位置所示。亦可看到，於一些實施例中，亦可選擇樣本流特徵1166及1168之位置，以控制樣本採集裝置1160中的填充速度、填充體積等等。應暸解，所述一項或多項特徵可適用於本文其他實施例中。 Please now refer to FIG. 11L, which illustrates an example of sample flow features 1166 and 1168. The cross-sectional view of the sample collection section with channels 1162 and 1164 and sample flow features 1166 and 1168 close to the common inlet path 1165 shows that in one embodiment, the features need to be located near the sample entry channel. Figure 11L also shows that for channels with different volumes, the inlet 1165 should be placed closer to the channel 1164 with a larger volume, as shown by the asymmetrical position of the inlet 1165. It can also be seen that in some embodiments, the positions of the sample flow features 1166 and 1168 can also be selected to control the filling speed, filling volume, etc. in the sample collection device 1160. It should be understood that the one or more features may be applicable to other embodiments herein.

現請參考圖11M，其繪示具有樣本防交叉流動特徵之通道1162及1164。於一個實施例中，所述樣本防交叉流動特徵為位於通道1162及1164至少一個表面上之排氣口1170及1172。於一個非限制性實例中，所述樣本防交叉流動特徵位於接近裝置中任意樣本流特徵1166及1168。於一個實施例中，所述防交叉流動特徵被配置為防止通道之間的流動。所述防交叉流動特徵可位於接近各通道最大填充位置附近，以便當通道達到或接近其最大樣本容量時，所述防交叉流動特徵1170及1172之位置防止過量填充樣本導致已於一條通道中加以處理之樣本進入另一條通道，出現來自兩條通道之樣本的不利混合。 Please refer now to FIG. 11M, which illustrates channels 1162 and 1164 with sample cross-flow prevention characteristics. In one embodiment, the sample anti-cross flow feature is vents 1170 and 1172 located on at least one surface of channels 1162 and 1164. In one non-limiting example, the sample anti-crossflow feature is located near any sample flow features 1166 and 1168 in the device. In one embodiment, the anti-cross flow feature is configured to prevent flow between channels. The cross-flow prevention feature can be located near the maximum filling position of each channel, so that when the channel reaches or approaches its maximum sample capacity, the position of the cross-flow prevention features 1170 and 1172 prevents overfilling of the sample resulting in the The processed sample enters another channel, and unfavorable mixing of samples from the two channels occurs.

圖11N繪示具有樣本填充指示器1112及1114之樣本採集裝置1160的透視圖。於一個實施例中，所述指 示器1112及1114為裝置1160之開口或透明部分，可籍此觀察通道1162或1164至少一部分。當樣本於所述指示器1112及1114至少之一中為可視時，其提示使用者隨即採取另一行動，諸如但不限於將樣本容器接合入支座1140。於一些實施例中，僅有一個樣本填充指示器，其代表兩條或更多條通道中樣本充足填滿。於一些實施例中，僅當所述指示器1112及1114如此指示時，方可採取接合樣本容器之行動。於一些實施例中，僅當所述指示器其中之一如此指示時，方可採取接合樣本容器之行動。 11N shows a perspective view of a sample collection device 1160 with sample fill indicators 1112 and 1114. In one embodiment, the finger The indicators 1112 and 1114 are openings or transparent parts of the device 1160, from which at least a part of the channel 1162 or 1164 can be observed. When the sample is visible in at least one of the indicators 1112 and 1114, it prompts the user to take another action immediately, such as but not limited to engaging the sample container into the support 1140. In some embodiments, there is only one sample filling indicator, which indicates that the samples in two or more channels are sufficiently filled. In some embodiments, only when the indicators 1112 and 1114 indicate so, can the action of engaging the sample container be taken. In some embodiments, the action of engaging the sample container can only be taken when one of the indicators so indicates.

現請參考圖11O、11P及11Q，其繪示圖11J所示裝置1160實施例之不同部位的剖視圖。圖11O繪示樣本流特徵1166及1168之剖視圖。亦繪示防交叉流動特徵1170及1172。亦可提供接合特徵1174，以使得各部件能夠共同配合形成裝置1160。 Now refer to FIGS. 11O, 11P, and 11Q, which illustrate cross-sectional views of different parts of the embodiment of the device 1160 shown in FIG. 11J. FIG. 110 shows a cross-sectional view of sample flow features 1166 and 1168. Anti-cross flow features 1170 and 1172 are also shown. Engagement features 1174 may also be provided to enable the various components to cooperate together to form the device 1160.

圖11P顯示，轉接通道1150及1152之佈置可延伸進入樣本通道1162及1164，或至少與其液體連通。可選地，一些實施例可具有多內腔轉接通道1150或1152。可選地，一些實施例對各樣本通道可具有多條轉接通道，其中該等額外通道可彼此相對平行、交錯、纏繞或具有其他定位。 FIG. 11P shows that the arrangement of the transition channels 1150 and 1152 can extend into the sample channels 1162 and 1164, or at least be in liquid communication with them. Optionally, some embodiments may have a multi-lumen transfer channel 1150 or 1152. Optionally, some embodiments may have multiple transition channels for each sample channel, where the additional channels may be relatively parallel, staggered, intertwined, or have other positioning relative to each other.

圖11Q顯示，於一些實施例中，容器支座1140可具有非對稱形狀(剖面平面)或其他形狀，使得支座1140僅可以一種定位被容納於裝置1160中。當需要將樣本從特定通道引導入選定容器中時，這尤為理想。如支座 1140可以各種定位被***，來自某一通道之樣本可最終進入錯誤容器中。可選地，可使用其他特徵，如對齊特徵、槽、視覺提示、紋路提示和/或其他等等，以促進實現樣本容器於裝置中優選定位。 FIG. 11Q shows that in some embodiments, the container holder 1140 may have an asymmetric shape (cross-sectional plane) or other shapes, so that the holder 1140 can be accommodated in the device 1160 in only one position. This is especially ideal when the sample needs to be directed from a specific channel into the selected container. Support 1140 can be inserted in various positions, and samples from a certain channel can finally enter the wrong container. Alternatively, other features such as alignment features, grooves, visual cues, texture cues, and / or others can be used to facilitate the preferred positioning of the sample container in the device.

一體化組織穿刺部件Integrated tissue piercing parts

現請參考圖11R，現將說明樣本採集裝置又一實施例。所述樣本採集裝置1210具有與圖11G所示相似特徵，惟其另行包括安裝於樣本採集裝置1210之上的組織穿刺部件。可使用諸如但不限於彈簧致動器等致動機制1214發動所述組織穿刺部件。圖11R繪示處於靜止狀態之致動機制1214，並顯示其可為能夠被壓縮以朝向目標組織發動組織穿刺部件1212之彈簧。所述組織穿刺部件1212可被容納於外殼1216(以假想線表示)中。於一個實施例中，外殼1216包括一個部分，其可被剝離、穿透、鬆開或以其他方式打開，從而使組織穿刺部件1212能夠退出外殼，卻又保持組織穿刺部件1212於使用前之無菌狀態。於一些實施例中，所述部分可為箔膜、蓋、聚合體層等等。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 Referring now to FIG. 11R, another embodiment of the sample collection device will now be described. The sample collection device 1210 has similar features as shown in FIG. 11G, but it additionally includes a tissue-piercing component mounted on the sample collection device 1210. The tissue-piercing member can be activated using an actuation mechanism 1214 such as, but not limited to, a spring actuator. FIG. 11R illustrates the actuation mechanism 1214 in a resting state and shows that it can be a spring that can be compressed to launch the tissue-piercing member 1212 toward the target tissue. The tissue-piercing member 1212 may be accommodated in a housing 1216 (represented by an imaginary line). In one embodiment, the housing 1216 includes a portion that can be peeled off, penetrated, loosened, or otherwise opened to allow the tissue-piercing member 1212 to exit the housing while maintaining the tissue-piercing member 1212 sterile before use status. In some embodiments, the portion may be a foil film, a cover, a polymer layer, etc. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

於一個實施例中，所述組織穿刺部件1212路徑可沿“正常”(即組織穿刺部件之向前方向)及“正交”(即與主移動矢量垂直)軌跡均加以控制。一些實施例可於穿刺最深點(即返回點)具有不具有強行停止或碰擊停止，其即為自發性疼痛之主要起因。一些實施例可使用軟 墊、凸輪路徑或其他非強行停止機制，以防止與突然停止衝擊波相關之疼痛。即使組織穿刺部件成功地避免碰及受傷位置鄰近之神經，此類衝擊波亦為有害的，蓋因所述衝擊波可於避免直接接觸情形下刺激該等神經。可選地，一些實施例可使組織穿刺部件遵循某一非顫動路徑，以防止形成粗暴創傷通道(餘痛)。於一些實施例中，透過用於組織穿刺部件之任何引導路徑或與組織穿刺部件相關之插針具有更嚴格容差，即可實現此點。此可為穿刺組織時某一非顫動路徑。可選地，此可為組織穿刺部件於組織外及組織內均遵循之非顫動路徑。由此可減少可導致餘痛、長期損傷及疤痕之組織穿刺部件總體“擺動”。 In one embodiment, the path of the tissue-piercing member 1212 can be controlled along both "normal" (ie, the forward direction of the tissue-piercing member) and "orthogonal" (ie, perpendicular to the main movement vector) trajectories. Some embodiments may have no forced stop or impact stop at the deepest point of the puncture (ie, return point), which is the main cause of spontaneous pain. Some embodiments may use soft Pads, cam paths, or other non-forced stop mechanisms to prevent pain associated with the sudden stop of shock waves. Even if the tissue-piercing member successfully avoids touching nerves adjacent to the injured location, such shock waves are harmful, and the shock waves can stimulate these nerves while avoiding direct contact. Optionally, some embodiments may allow the tissue-piercing component to follow a certain non-vibrating path to prevent the formation of a rough trauma channel (residual pain). In some embodiments, this can be achieved through any guide path for the tissue-piercing component or the pins associated with the tissue-piercing component with tighter tolerances. This may be a non-vibrating path when puncturing tissue. Alternatively, this may be a non-trembling path that the tissue-piercing member follows both outside and inside the tissue. This can reduce the overall "swing" of the tissue-piercing components that can cause residual pain, long-term damage and scars.

一些實施例可具有受控拔出速度，以防止緩慢、延誤之傷口癒合及事後流血。作為非限制性實例，可籍由諸如但不限於凸輪或較高摩擦材料等機械機制控制組織穿刺部件之受控拔出速度。 Some embodiments may have a controlled extraction speed to prevent slow, delayed wound healing and bleeding afterwards. As a non-limiting example, the controlled extraction speed of the tissue-piercing component can be controlled by mechanical mechanisms such as, but not limited to, cams or higher friction materials.

一些實施例亦可包括防跳動機制，以防止於首次產生創傷後，因未經控制之組織穿刺部件彈回組織中，從而造成之意外再次產生切口。本文一些實施例可具有“停放”機制或閉鎖機制，其將接合組織穿刺部件或其附件，以防止組織穿刺部件於抽出組織或具有一些其他所需距離後，再次進入組織中。 Some embodiments may also include an anti-jump mechanism to prevent accidental re-incisions caused by uncontrolled tissue puncturing components bounced back into the tissue after the first trauma. Some embodiments herein may have a "parking" mechanism or latching mechanism that will engage the tissue-piercing component or its accessories to prevent the tissue-piercing component from re-entering the tissue after it has been withdrawn or has some other desired distance.

刺血針於皮膚中最大深度處開始其拔出動作，並返回其開始位置前停止之突然性為此設計之固有問題。當刺血針位於其最深穿刺點處時，對皮膚施加最大力。如 同球從地板上彈起，此推動機制簡單地從裝置末端彈起。於其刺入動作結束點處突然停止之刺血針向皮膚內送入衝擊波，點燃鄰近刺血針之眾多疼痛受體，即便它們未被直接擊中。這相當大程度地增加自發性疼痛。 The suddenness of the lancet to start its extraction at the maximum depth in the skin and stop before returning to its starting position is an inherent problem with this design. When the lancet is at its deepest puncture point, the maximum force is applied to the skin. Such as The same ball bounces from the floor, and this pushing mechanism simply bounces from the end of the device. The lancet that suddenly stopped at the end of its piercing action sent a shock wave into the skin, igniting many pain receptors adjacent to the lancet, even if they were not directly hit. This considerably increases spontaneous pain.

如前所述，一些實施例可採用機械凸輪致動取代簡單彈簧致動之組織穿刺部件。具有凸輪致動設計之裝置可將組織穿刺部件之“硬行停止”減至最少。凸輪機制通常為彈簧驅動，且一般提供較佳導引致動。籍由組織穿刺部件支座之導引路徑透過於凸輪上行進之插針嚴密控制組織穿刺部件之軌跡。凸輪機制可為組織穿刺部件之拔出軌跡實現預定速度特徵，較柔軟返回及獨特速度控制。此機制亦有效地避免刺血針於機制到達其運動終點時反彈進入皮膚。另外，當於大氣中動作時，刺血針於兩個方向之機械振動(或顫動/擺動)均得到減少。本文一些實施例亦可將驅動機制之任意擺動(如，因不平整或粗糙凸輪槽)減至最少，以防止此類驅動機制擺動因其“強制動作特徵”而直接傳遞入組織中。 As previously mentioned, some embodiments may use mechanical cam actuation instead of simple spring-actuated tissue-piercing components. The device with cam actuation design can minimize the "hard stop" of the tissue-piercing component. The cam mechanism is usually spring driven and generally provides better guidance actuation. The guide path of the support of the tissue-piercing member strictly controls the trajectory of the tissue-piercing member through the pins traveling on the cam. The cam mechanism can achieve a predetermined speed characteristic for the pull-out trajectory of the tissue-piercing component, softer return and unique speed control. This mechanism also effectively prevents the lancet from bouncing back into the skin when the mechanism reaches its end of motion. In addition, when operating in the atmosphere, the mechanical vibration (or tremor / swing) of the lancet in both directions is reduced. Some embodiments herein may also minimize any swinging of the driving mechanism (eg, due to unevenness or rough cam grooves) to prevent such driving mechanism swinging from being directly transmitted into the tissue due to its "forced motion feature".

可選地，一些實施例可籍由電子控制驅動機制，採用電子致動。此技術運用與極精確位置傳感器耦合之微型電子馬達(如音圈、螺線管)，以精確控制之動作及速度將組織穿刺部件移入及移出皮膚。於快速進入後，裝置使組織穿刺部件減速至確切之預設深度，平穩地、無顫動地且較慢地返回。這實現快速傷口癒合並避免長期創傷。嚴密控制組織穿刺部件致動“特徵”之益處為可重複 無痛切口，其可採得充足、一致的血樣用於測試。 Alternatively, some embodiments may employ electronic actuation via an electronically controlled drive mechanism. This technology uses a miniature electronic motor (such as a voice coil and solenoid) coupled with an extremely precise position sensor to move the tissue-piercing component into and out of the skin with precisely controlled motion and speed. After rapid entry, the device decelerates the tissue-piercing component to the exact preset depth, returning smoothly, without tremor, and slowly. This enables rapid wound healing and avoids long-term trauma. The benefits of tightly controlling the activation of the "features" of tissue-piercing components are repeatable Painless incision, which can take a sufficient and consistent blood sample for testing.

就用於血樣抽取之產生穿刺點而言，宜於病患非慣用手手指(無名指或中指)之一上選擇合適穿刺點。穿刺點可位於手指尖兩側。於一個非限制性實例中，宜將暖手帶置於所選病患手指上15秒。可選地，一些實施例可溫暖病患手指10至60秒。其他實施例可溫暖更長時間。所述溫暖將加快流至目標點之血流。為準備目標點，宜用酒精紙巾或類似清潔物品擦拭所選手指之側面指頭或對象表面，確保擦拭所選穿刺點。於一些實施例中，宜等待皮膚完全乾燥。通常不需用薄紗乾燥或向指頭吹風以加速乾燥。 As far as the puncture point for blood sample extraction is concerned, it is appropriate to select a suitable puncture point on one of the patient's non-dominant fingers (ring finger or middle finger). The puncture point can be on both sides of the fingertip. In a non-limiting example, the hand warmer should be placed on the finger of the selected patient for 15 seconds. Optionally, some embodiments may warm the patient's finger for 10 to 60 seconds. Other embodiments may be warmer for longer. The warmth will accelerate the blood flow to the target point. To prepare for the target point, it is advisable to wipe the side fingers or object surface of the selected finger with alcohol paper towels or similar cleaning items to ensure that the selected puncture point is wiped. In some embodiments, it is advisable to wait for the skin to dry completely. Normally, there is no need to dry the tissue or blow the fingers to speed up the drying.

於穿刺完成後，將手指保持向下低於病患腰部，以便血液流動。自底部至指頭輕輕按摩手指，直至出現血滴。小心地使血液採集裝置尖端接觸手指上血珠，由此填充該裝置。確保所述裝置完全填滿。當血液採集裝置被填滿後，將手指出血部位按壓至桌上紗墊。傳遞血樣進入採集容器。將繃帶置於手指上。將帶有樣本之容器置於冷藏庫內裝運盒中。將所有物品丟棄入生物危害尖銳物容器中。所有物品均為一次性使用。 After the puncture is completed, keep your fingers below the patient's waist to allow blood to flow. Gently massage your fingers from the bottom to the fingers until blood drops appear. Carefully bring the tip of the blood collection device into contact with the blood bead on the finger, thereby filling the device. Make sure that the device is completely filled. After the blood collection device is filled, press the bleeding part of the finger to the gauze pad on the table. Pass the blood sample into the collection container. Put the bandage on your finger. Place the container with the sample in the shipping box in the refrigerator. Discard all items in containers of sharp biohazards. All items are disposable.

如第一次穿刺未能獲得充足血液，小心地將血液採集裝置置於桌面上，確保所述裝置保持水平。將繃帶置於被穿刺之手指上。於病患同一只手之不同手指上選擇合適穿刺點。如第一次穿刺無名指，則在中指上選擇新穿刺點，反之亦然。將暖手帶置於所選病患手指上60秒。可 選地，一些實施例可溫暖病患手指30至90秒。這將加快流至手指之血流。採用如本文所述之運用樣本採集裝置的任意血液採集技術，可採集充足毛細血管血液樣本，用於經臨床實驗室改進修正案(CLIA)認證設施和/或標準進行之實驗室測試。 If sufficient blood is not obtained for the first puncture, carefully place the blood collection device on the table to ensure that the device remains level. Place the bandage on the punctured finger. Select the appropriate puncture point on different fingers of the same hand of the patient. If puncturing the ring finger for the first time, select a new puncture point on the middle finger and vice versa. Place the hand warmer on the finger of the selected patient for 60 seconds. can Optionally, some embodiments may warm the patient's finger for 30 to 90 seconds. This will speed up the blood flow to the fingers. Using any blood collection technique using a sample collection device as described herein, sufficient capillary blood samples can be collected for laboratory testing conducted by the Clinical Laboratory Improvement Amendment (CLIA) certification facility and / or standards.

現請參考圖11S，現將說明樣本採集裝置1220之又一實施例。於本實施例中，組織穿刺部件1222可相對於樣本採集裝置1220成角度安裝。此成角度配置使得組織穿刺部件能夠於與樣本獲取開口1103及1105對齊位置產生傷口。儘管圖中繪示標準彈簧發動之致動器作為組織穿刺部件1222之驅動機制1224，應暸解，凸輪和/或電氣驅動系統亦可代替彈簧發動器或與之組合使用。當驅動機制1224為彈簧時，所述彈簧可經壓縮，將組織穿刺部件1222移動至發動位置，並鬆開，穿刺進入目標組織。圖11S繪示處於靜止狀態之組織穿刺部件1222。儘管圖中繪示彈簧為驅動機制1224，應暸解，並未排除適合用於發動組織穿刺部件以於對象上產生可癒合傷口之其他驅動機制。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 11S, another embodiment of the sample collection device 1220 will now be described. In this embodiment, the tissue-piercing member 1222 may be installed at an angle relative to the sample collection device 1220. This angled configuration allows the tissue-piercing member to create a wound in alignment with the sample acquisition openings 1103 and 1105. Although the figure shows a standard spring-actuated actuator as the drive mechanism 1224 of the tissue-piercing member 1222, it should be understood that a cam and / or electric drive system can also replace or be used in combination with the spring actuator. When the driving mechanism 1224 is a spring, the spring can be compressed to move the tissue-piercing member 1222 to the firing position, and release, and the puncture enters the target tissue. FIG. 11S illustrates the tissue-piercing member 1222 in a static state. Although the spring is shown as the driving mechanism 1224 in the figure, it should be understood that other driving mechanisms suitable for activating the tissue-piercing member to produce a healable wound on the subject are not excluded. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

可圍繞組織穿刺部件1222形成類似外殼1216之外殼1226。儘管圖11S繪示安裝於樣本採集裝置之上的兩個組織穿刺部件1222，應暸解，並未排除具有更多或更少組織穿刺部件之裝置。舉例而言，一些實施例可僅具有安裝於樣本採集裝置1220之上的一個組織穿刺部件 1222。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 A shell 1226 similar to the shell 1216 may be formed around the tissue-piercing member 1222. Although FIG. 11S illustrates two tissue-piercing components 1222 mounted on the sample collection device, it should be understood that devices having more or fewer tissue-piercing components are not excluded. For example, some embodiments may have only one tissue-piercing component mounted on the sample collection device 1220 1222. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

現請參考圖11T，現將說明樣本採集裝置1230之另一實施例。此實施例顯示，組織穿刺部件1232被容納於樣本採集裝置1230中，且如圖11T所示，其實際上與所述樣本採集裝置之中心軸共軸對齊。這使得組織穿刺部件1232佈置為於接近開口1103及1105於樣本採集裝置1230上之位置處，從樣本採集裝置1230朝外延伸。當然，並未排除具有更多或更少開口之裝置，圖11T所示實施例僅為示例性、非限制性。圖11T顯示，於一個樣本採集裝置實施例中，可於樣本採集裝置1230上安裝發動按鈕1234。可選地，一些實施例可具有成型前端1236作為致動按鈕，其中當前端1236抵壓組織至特定深度和/或特定壓力時，組織穿刺部件將被致動。 Referring now to FIG. 11T, another embodiment of the sample collection device 1230 will now be described. This embodiment shows that the tissue-piercing member 1232 is contained in the sample collection device 1230, and as shown in FIG. 11T, it is actually coaxially aligned with the central axis of the sample collection device. This causes the tissue-piercing member 1232 to be arranged at a position on the sample collection device 1230 near the openings 1103 and 1105, extending outward from the sample collection device 1230. Of course, devices with more or fewer openings are not excluded, and the embodiment shown in FIG. 11T is merely exemplary and non-limiting. FIG. 11T shows that, in an embodiment of a sample collection device, an activation button 1234 can be installed on the sample collection device 1230. Optionally, some embodiments may have a shaped front end 1236 as an actuation button, where when the front end 1236 presses tissue to a certain depth and / or a certain pressure, the tissue-piercing member will be actuated.

一旦發動，組織穿刺部件1232按箭頭1233所示移動。於一些實施例中，組織穿刺部件1232於致動前被完全容納於樣本採集裝置1230中。一些實施例可於裝置1230上具有視覺指示器1235，以幫助引導使用者了解組織穿刺部件1232將於何處退出裝置，且傷口大約將於何處形成。 Once activated, the tissue-piercing member 1232 moves as indicated by arrow 1233. In some embodiments, the tissue-piercing member 1232 is fully contained in the sample collection device 1230 before actuation. Some embodiments may have a visual indicator 1235 on the device 1230 to help guide the user as to where the tissue-piercing member 1232 will exit the device and where the wound will form.

於此非限制性實例中，整個裝置1230可位於無菌袋或包裝中，其僅於裝置1230使用時方才打開。如此，組織穿刺部件及採集裝置於使用前將保持無菌狀態。此外部無菌袋或包裝亦適用於本文中任意其他實施例。圖11L 亦顯示，成型前端1236(以假想線表示)可與樣本採集裝置1230一體形成，或單獨附屬於該裝置。此成型前端1236可提供吸力將樣本液體吸入樣本採集裝置1230。可選地，成型前端1236可被用於拉伸目標組織和/或強制其進入成型前端，以施加壓力，從而提高組織穿刺部件1232形成之傷口的樣本液體產出。應暸解，本文中任意實施例可適用於具有成型前端1236。可選地，成型前端可具有選定恐水區域，以引導樣本液體至所述前端上的一個或多個採集區域。可選地，成型前端可具有選定親水區域，以引導樣本液體至所述前端上的一個或多個採集區域。 In this non-limiting example, the entire device 1230 may be located in a sterile bag or package, which only opens when the device 1230 is used. In this way, the tissue-piercing component and the collection device will remain sterile before use. The outer sterile bag or packaging is also applicable to any other embodiments herein. Figure 11L It has also been shown that the shaped front end 1236 (represented by an imaginary line) can be integrally formed with the sample collection device 1230 or attached separately to the device. The shaped front end 1236 can provide suction to draw the sample liquid into the sample collection device 1230. Alternatively, the shaping front end 1236 may be used to stretch the target tissue and / or force it into the shaping front end to apply pressure, thereby increasing the sample fluid output of the wound formed by the tissue-piercing member 1232. It should be understood that any of the embodiments herein may be adapted to have a shaped front end 1236. Optionally, the shaped front end may have a selected water-repellent area to guide the sample liquid to one or more collection areas on the front end. Optionally, the shaped front end may have a selected hydrophilic area to guide sample liquid to one or more collection areas on the front end.

現請參考圖11U，現將說明樣本採集裝置之又一實施例。此實施例與圖11T相似，惟圖11T之實施例採用複數個組織穿刺部件1242，而不是單個組織穿刺部件，如刺血針。於一個實施例中，這些組織穿刺部件為與習用刺血針相比具有縮減直徑之微針1242。可為裝置1240同時致動複數個微針1242，並於組織上產生多個傷口。微針1242間距可導致更多毛細管被穿刺，且提供更多通道以便血液到達組織表面。與具有尖銳頂端及錐形輪廓之刺血針相比，這可實現更為“方正”之穿刺特徵。這亦使得微針1242能夠於較大面積上接觸更多毛細管，而不會因穿刺過深而進入具有更密集神經末梢之較深組織層。 Referring now to FIG. 11U, another embodiment of the sample collection device will now be described. This embodiment is similar to FIG. 11T, but the embodiment of FIG. 11T uses a plurality of tissue-piercing components 1242 instead of a single tissue-piercing component, such as a lancet. In one embodiment, these tissue-piercing components are micro-needle 1242 with a reduced diameter compared to conventional lancets. The device 1240 can simultaneously activate a plurality of microneedles 1242 and create multiple wounds on the tissue. The microneedle 1242 pitch can cause more capillaries to be punctured and provide more channels for blood to reach the tissue surface. Compared with a lancet with a sharp tip and a tapered profile, this can achieve a more "square" puncture feature. This also allows the microneedle 1242 to contact more capillaries on a larger area without entering the deeper tissue layer with denser nerve endings due to the deep puncture.

現請參考圖11V及11W，現將說明樣本採集裝置之又一實施例。於圖中所示實施例中，樣本採集裝置1100可成角度地安裝於專用傷口產生裝置1250上，其具 有被配置為從裝置1250朝外延伸之組織穿刺部件1252。樣本採集裝置1100可選地被配置為具有成型前端1236(帶有或不帶有容納組織穿刺部件1252之開口)，並以可移除方式安裝於傷口產生裝置1250上。可選地，樣本採集裝置1100可被平坦安裝至裝置1250。可選地，裝置1250上可具有成型切割口，以透過壓入配合固定樣本採集裝置1100。應暸解，並未排除以可移除方式安裝樣本採集裝置1100之其他技術。因採集裝置與傷口產生裝置之此種分離，可採用更為複雜、有可能非一次性之傷口產生裝置1250，其可產生更經控制、減少疼痛之傷口產生體驗。 Referring now to FIGS. 11V and 11W, another embodiment of the sample collection device will now be described. In the embodiment shown in the figure, the sample collection device 1100 may be installed at an angle on a dedicated wound generating device 1250, which has There is a tissue-piercing member 1252 configured to extend outward from the device 1250. The sample collection device 1100 is optionally configured with a shaped front end 1236 (with or without an opening to receive the tissue-piercing member 1252), and is removably mounted on the wound generating device 1250. Alternatively, the sample collection device 1100 may be flat mounted to the device 1250. Optionally, the device 1250 may have a shaped cutting port to fix the sample collection device 1100 through press-fitting. It should be understood that other techniques for installing the sample collection device 1100 in a removable manner are not excluded. Because of this separation of the collection device and the wound-generating device, a more complex, possibly non-disposable wound-generating device 1250 can be used, which can produce a more controlled, pain-reducing wound-generating experience.

圖11W顯示，樣本採集裝置1100可經安排，使之大致上水平，以致不影響樣本採集所受之重力效應。並未排除裝置1100安裝於傷口產生裝置1250的其他配置。 FIG. 11W shows that the sample collection device 1100 can be arranged so as to be substantially horizontal so as not to affect the gravitational effect suffered by the sample collection. Other configurations where the device 1100 is installed in the wound generating device 1250 are not excluded.

現請參考圖11X至11Z，現將說明各種樣本採集裝置之更多實施例。圖11X繪示樣本採集裝置1240，裝置1240上可使用成型前端1236。此成型前端1236與前述內容相似。可使用真空源1270幫助將體液樣本抽吸入裝置1240中。真空源1270可與裝置1240和/或成型前端1236相連。應暸解，本文所述任意實施例均可適合使用樣本獲取幫助裝置，諸如但不限於真空源1270。 Referring now to FIGS. 11X to 11Z, more embodiments of various sample collection devices will now be described. FIG. 11X illustrates a sample collection device 1240. A molding front end 1236 can be used on the device 1240. The molding front end 1236 is similar to the foregoing. A vacuum source 1270 may be used to help draw a sample of body fluid into the device 1240. The vacuum source 1270 may be connected to the device 1240 and / or the forming front end 1236. It should be appreciated that any of the embodiments described herein may be suitable for use with sample acquisition assistance devices, such as but not limited to vacuum source 1270.

圖11Y繪示樣本採集裝置之又一實施例。此實施例運用具有管頭1280之吸量管系統採集樣本液體。所述管頭可包括同軸安裝之組織穿刺部件1282。可選地，側安裝或成角度之組織穿刺部件1284如圖所示，於目標點產生 傷口。此具有管頭1280之吸量管系統可運用真空將樣本液體從對象中取出。可選地，可與管頭1280一起採用成型前端1236，以幫助於目標點拉伸皮膚或組織整形。 FIG. 11Y illustrates another embodiment of the sample collection device. This embodiment uses a pipette system with a tube head 1280 to collect the sample liquid. The tube head may include a tissue-piercing member 1282 mounted coaxially. Optionally, the side-mounted or angled tissue-piercing member 1284 is generated at the target point as shown in the figure wound. This pipette system with a tube head 1280 can use vacuum to remove the sample liquid from the subject. Optionally, a shaped front end 1236 can be used with the tube head 1280 to help stretch the skin or tissue shaping at the target point.

圖11Z顯示，一些實施例可運用橫膈膜1291所連接之致動機制為抽吸血樣生成真空。此連接可使橫膈膜於組織穿刺部件1292自目標點返回行程中生成真空。於一個實施例中，組織穿刺部件1292為微針。如箭頭1294所示組織穿刺部件之致動發動組織穿刺部件1292，並於返回路徑上，因與組織穿刺部件1292動作相連之橫膈膜的動作而生成真空。一個或多個容器1296可耦合，以容納裝置1290採集之液體。一些實施例可僅具有一個容器1296。一些實施例可具有一套容器1296。一些實施例可具有多套容器1296。一些實施例可外部安裝於裝置1290上。一些實施例可內部安裝於裝置1290中。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 FIG. 11Z shows that some embodiments may use the actuation mechanism connected to the diaphragm 1291 to generate a vacuum for drawing blood samples. This connection allows the diaphragm to generate a vacuum during the return stroke of the tissue-piercing member 1292 from the target point. In one embodiment, the tissue-piercing member 1292 is a microneedle. As indicated by arrow 1294, the activation of the tissue-piercing member activates the tissue-piercing member 1292, and on the return path, a vacuum is generated due to the action of the diaphragm connected to the tissue-piercing member 1292 in operative connection. One or more containers 1296 may be coupled to contain the liquid collected by the device 1290. Some embodiments may have only one container 1296. Some embodiments may have a set of containers 1296. Some embodiments may have multiple sets of containers 1296. Some embodiments may be externally mounted on the device 1290. Some embodiments may be internally installed in the device 1290. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

垂直流出限流器Vertical outflow restrictor

圖11E亦更清晰地顯示，轉接器1150及1152周圍係有套管1156。儘管僅於圖11A-11F中示出，應暸解，帶有或不帶有排氣口之套管可被配置用於本文所述之任意實施例中。如圖11E之實施例所示，通道可由針頭限定。所述套管1156防止液體樣本於容器1146a及1146b接合針頭前，過早地從轉接通道1150及1152中流出。因所要獲取樣本液體之小體積，防止過早流動減少了與液體自 通道傳遞至容器相關之液體損失量。於一個實施例中，所述套管1156可籍由提供液體密封而不是空氣密封之套管，將所述液體損失減至最少。如所述套管為空氣密封，其將妨礙通道毛細作用正常工作。可選地，一些實施例可將排氣口設置於接近針頭底部，離開針頭，以便套管可於離開排氣口之位置容納樣本。 Fig. 11E also shows more clearly that the adapters 1150 and 1152 are surrounded by sleeves 1156. Although only shown in FIGS. 11A-11F, it should be understood that the sleeve with or without the exhaust port may be configured for use in any of the embodiments described herein. As shown in the embodiment of FIG. 11E, the channel may be defined by the needle. The cannula 1156 prevents liquid samples from prematurely flowing out of the adapter channels 1150 and 1152 before the containers 1146a and 1146b engage the needle. Because of the small volume of the sample liquid to be obtained, preventing premature flow reduces the The amount of liquid loss associated with the passage to the container. In one embodiment, the sleeve 1156 can be provided with a liquid seal rather than an air seal to minimize the loss of liquid. If the sleeve is air-tight, it will prevent the capillary action of the channel from working properly. Optionally, some embodiments may place the vent near the bottom of the needle, away from the needle, so that the cannula can contain the sample at a location away from the vent.

圖11F顯示，於一個示範性實施例中，所述套管1156被配置為具有通過套管之開口1158。相較通常為鬆弛套於針頭之上的習用套管，這使得實施例得到改良。因習用套管中的鬆弛配合，針頭與套管之間係存在有針頭及側壁空間，液體樣本可於其中積聚。儘管相對於可持續損失液體之不帶套管針頭，此種套管設計籍由限制液體損失至限定液量，進而有助於防止更大之液體損失，然沿針頭及側壁之套管區域積聚之液體依然被損失，且不為容器1146a或1146b採集。所述套管1156亦可包括變窄區域1176，以促進套管與裝置之配合，提供與通道1126及1128之液體連通，諸如但不限於針頭、探針、管、通道或其他轉接通道1150。 FIG. 11F shows that, in an exemplary embodiment, the sleeve 1156 is configured to have an opening 1158 through the sleeve. Compared with the conventional cannula which loosely fits over the needle, this improves the embodiment. Due to the loose fit in the conventional cannula, there is a space between the needle and the cannula and the side wall where liquid samples can accumulate. Although this type of cannula design restricts fluid loss to a limited volume compared to a non-cannulated needle that can sustain fluid loss, it can help prevent greater fluid loss, but accumulates along the cannula area of the needle and sidewall The liquid is still lost and is not collected for container 1146a or 1146b. The cannula 1156 may also include a narrowed region 1176 to facilitate the cooperation of the cannula and the device to provide fluid communication with channels 1126 and 1128, such as but not limited to needles, probes, tubes, channels, or other transition channels 1150 .

於圖11F所示實施例中，開口1158按計算設置尺寸，所述計算足以承受因由樣本填充部分1120中通道之毛細作用產生液流所造成的液體壓力。此力使得開口1158能夠排放來自通道之氣，亦可防止液體離開套管，直至容器1146a及1146b被推動與轉接通道1150及1152接合。因開口1158產生之排放效應，相較於習用套管，套管側壁 及其他區域可被製成與針頭形成更為緊密之配合。這減少針頭與套管之間的間隙空間，相較於無排氣孔並因鬆弛配合而具有大很多之間隙空間的套管，其因此將液體損失量減至最少。另外，開口1158尺寸亦可設置為，當液體到達開口時，其提供充足阻力，使得流出通道或針頭之液流亦被停止，因而損失至套管與針頭尖端之間任意間隙中的液體為最小。 In the embodiment shown in FIG. 11F, the opening 1158 is sized according to a calculation that is sufficient to withstand the liquid pressure caused by the liquid flow generated by the capillary action of the channel in the sample filling portion 1120. This force allows the opening 1158 to vent gas from the channel, and also prevents liquid from leaving the sleeve until the containers 1146a and 1146b are pushed into engagement with the transition channels 1150 and 1152. Compared to conventional bushings, the discharge effect due to the opening 1158 has side walls And other areas can be made to form a closer fit with the needle. This reduces the interstitial space between the needle and the cannula, which, compared to cannulas without vent holes and having a much larger interstitial space due to the loose fit, therefore minimizes the amount of fluid loss. In addition, the size of the opening 1158 can also be set so that when the liquid reaches the opening, it provides sufficient resistance, so that the flow of the outflow channel or the needle is also stopped, so the loss of liquid to any gap between the cannula and the needle tip is minimal .

圖12繪示設置開口尺寸之計算，其旨在平衡各種力，使得限定排氣口之恐水材料提供充足防洩漏力，以遏制樣本液體流出套管外。圖12中，套管1156之側壁可與針頭直接接觸，或於一些實施例中，可沿側壁與套管具有一間隙。於一個實施例中，套管1156包括一種恐水材料，諸如但不限於熱塑彈性體(TPE)、丁基合成橡膠、矽樹脂或其他恐水材料。於一個實施例中，套管厚度亦可決定套管1156中開口或排氣口1158側壁之長度。 FIG. 12 illustrates the calculation of the size of the opening, which aims to balance various forces so that the water-repellent material defining the exhaust port provides sufficient anti-leakage force to prevent the sample liquid from flowing out of the casing. In FIG. 12, the side wall of the cannula 1156 may be in direct contact with the needle, or in some embodiments, there may be a gap along the side wall with the cannula. In one embodiment, the sleeve 1156 includes a water-repellent material, such as but not limited to thermoplastic elastomer (TPE), butyl synthetic rubber, silicone, or other water-repellent material. In one embodiment, the thickness of the sleeve may also determine the length of the opening in the sleeve 1156 or the side wall of the vent 1158.

開口1158可位於沿套管1156之一個或多個位置。其於一些實施例中可如圖12所示。或者，一些實施例可於套管側壁上具有開口1158。並未排除其他位置。可選地，套管1156可具有通過套管之多個開口，惟其配置為，液體不離開套管，且開口之阻力足以防止額外液體流離通道，直至容器1146a或1146b與通道接合並液體連通。 The opening 1158 may be located at one or more locations along the sleeve 1156. It may be as shown in FIG. 12 in some embodiments. Alternatively, some embodiments may have an opening 1158 in the side wall of the sleeve. Other locations are not excluded. Alternatively, the sleeve 1156 may have multiple openings through the sleeve, but it is configured such that the liquid does not leave the sleeve and the resistance of the opening is sufficient to prevent additional liquid from flowing out of the channel until the container 1146a or 1146b engages the channel and is in liquid communication.

對於如何使用裝置1100採集樣本，於一種技術中，樣本採集裝置1100被保持與目標體液接觸，並被固定直至達到所需填充程度。於此期間，裝置1100可被水平保 持，以將當裝置1100被較垂直保持時所需克服之重力降至最小。當所需填充程度達到時，裝置1100可與目標液體脫離，隨後容器1146a及1146b接合，將所採集液體抽吸入容器中。可選地，裝置1100可繼續與目標液體保持接觸，而容器與通道形成液體接觸，以便抽吸通道中液體，以及還可能抽吸依然停留於目標點之任何額外樣本液體。這可確保充足體液被抽吸入容器中。 Regarding how to use the device 1100 to collect samples, in one technique, the sample collection device 1100 is kept in contact with the target body fluid and is fixed until the desired filling level is reached. During this period, the device 1100 can be To minimize the gravity that needs to be overcome when the device 1100 is held more vertically. When the required filling level is reached, the device 1100 can be disengaged from the target liquid, and then the containers 1146a and 1146b are engaged to draw the collected liquid into the container. Alternatively, the device 1100 may continue to be in contact with the target liquid while the container is in liquid contact with the channel in order to aspirate the liquid in the channel and possibly also any additional sample liquid that remains at the target point. This ensures that sufficient body fluid is drawn into the container.

填滿容器1146a及1146b後，其可被準備進行運輸。可選地，其可於運輸前進行前處理。容器1146a及1146b之一些實施例於容器中包括一種材料，其密度為經過諸如離心分離等前處理後，所述材料因其所選密度，將所離心分離之樣本一部分與其另一部分於同一容器中分離。 After the containers 1146a and 1146b are filled, they can be prepared for transportation. Alternatively, it can be pre-treated before transportation. Some embodiments of containers 1146a and 1146b include a material in the container whose density is such that after pretreatment such as centrifugal separation, the material will centrifuge the part of the sample and the other part in the same container due to its selected density Separate.

容器1146a或1146b可於其中具有真空和/或負壓。當通道與真空容器形成液體連通時，樣本即可被吸入容器中。可選地，所述容器可採用如同試管之裝置形式，等同於新澤西東拉瑟福德美商必帝股份有限公司以商標“Vacutainer”銷售之容器。所述裝置可保持於壓縮狀態，其基座1140關閉間隙1154，與此同時樣本被傳遞至容器。樣本可填滿整個容器或容器之一部分。來自通道之樣本整體(和/或大於90%、95%、97%、98%、99%、99.5%或99.9%的樣本)可被傳遞至容器。或者，來自通道之樣本僅有一部分被傳遞至容器。 The container 1146a or 1146b may have vacuum and / or negative pressure therein. When the channel is in liquid communication with the vacuum container, the sample can be drawn into the container. Alternatively, the container may be in the form of a test tube-like device, which is equivalent to a container sold under the trademark "Vacutainer" of American Rutherford, New Jersey. The device can be kept in a compressed state with its base 1140 closing the gap 1154 while the sample is transferred to the container. The sample can fill the entire container or part of the container. The entire sample from the channel (and / or samples greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9%) can be delivered to the container. Alternatively, only a portion of the sample from the channel is transferred to the container.

於本文所述一個實施例中，向樣本採集裝置 1100進行兩步樣本液體填充，可實現i)樣本液體計量採集，確保於採集通道中獲得充足液量，並經處理以防止過早凝固，及隨後ii)將高比例樣本液體傳遞入容器中之有效方式。這樣自預先填充的通道低損失地填充至容器，去計量最少量之樣本液體填充至容器1146，其具有多個優點，尤其是當處理採集小體積樣本液體時。預先填充通道至所需程度確保容器中存在足夠液量，得以對樣本液體進行所需測試。 In one embodiment described herein, the sample collection device 1100 carries out two steps of sample liquid filling, which can achieve i) sample liquid metering collection, ensure that sufficient liquid volume is obtained in the collection channel, and be processed to prevent premature solidification, and then ii) transfer a high proportion of sample liquid into the container Effective way. In this way, the container is filled with low loss from the pre-filled channel, and the smallest amount of sample liquid is filled into the container 1146, which has several advantages, especially when processing a small volume of sample liquid. Pre-fill the channel to the required degree to ensure that there is sufficient liquid in the container to perform the required test on the sample liquid.

如本文所述，包括樣本填充部分1120、支架1130及基座1140之整個裝置為全透明或半透明，以便視覺觀察其中部件。可選地，樣本填充部分1120、支架1130及基座1140中僅有一個為全透明或半透明。可選地，樣本填充部分1120、支架1130或基座1140中僅有選定部分為全透明或半透明。使用者隨後視樣本液體填充進展及樣本容器與樣本填充部分1120中通道之接合，可更精確地決定何時執行各種程序。採集通道中氣泡於填充過程中為可視，且如果觀察到氣泡，使用者可調整樣本採集裝置1100之位置，以更佳地接觸目標樣本液體，進而使被吸入通道之空氣減至最少。其亦將使得使用者能夠了解，當填充完成後，何時分離或脫離基座或容器支座1140等各部件。 As described herein, the entire device including the sample filling portion 1120, the holder 1130, and the base 1140 is fully transparent or translucent, so as to visually observe the components therein. Optionally, only one of the sample filling portion 1120, the bracket 1130, and the base 1140 is fully transparent or translucent. Optionally, only selected portions of the sample filling portion 1120, the holder 1130, or the base 1140 are fully transparent or translucent. The user can then more accurately decide when to perform various procedures depending on the progress of the sample liquid filling and the engagement of the sample container with the channel in the sample filling portion 1120. The bubbles in the collection channel are visible during the filling process, and if bubbles are observed, the user can adjust the position of the sample collection device 1100 to better contact the target sample liquid, thereby minimizing the air drawn into the channel. It will also allow the user to understand when the filling is complete, when to separate or disengage the base or container support 1140 and other components.

應暸解，如裝置被保持於非水平角度，諸如但不限於垂直向下，可採用其他方法防止樣本自轉接通道1150及1152朝外流動。於一個實施例中，可與針頭一起 採用熔塊1194，其具有中心孔用作轉接通道1150及1152。該熔塊可位於樣本採集裝置中或位於採集器皿上。於一些實施例中，該熔塊由諸如但不限於PTFE等材料構成。可選地，一些實施例可於作為轉接通道1150及1152之針頭上運用膠帶/粘劑。於一個實施例中，所述膠帶/粘劑可被用於覆蓋針頭開口以防止過早排出樣本。可選地，一些實施例可包含具有恐水表面之轉接通道1150及1152，以防止受控流從通往樣本容器之轉接通道開口中流出。於一些實施例中，轉接通道1150及1152為僅於接近出口之內表面上具有恐水材料之針頭。可選地，所述恐水材料僅位於接近出口之外表面上。可選地，所述恐水材料位於針頭內表面及外表面上。可選地，防止向下流的另一方法為籍由變化剖面，增加毛細管之表面積。作為非限制性實例，一些實施例可於毛細管中引入類似牙或手指之結構，以增加毛細管剖面面積。可選地，一些實施例可包括定位朝向和/或相反於毛細管中液體流之鰭狀物，以增加毛細管剖面面積。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 It should be appreciated that if the device is held at a non-horizontal angle, such as but not limited to vertical downward, other methods may be used to prevent the sample from flowing outward from the transition channels 1150 and 1152. In one embodiment, it can be used together with the needle A frit 1194 is used, which has a central hole used as a transition channel 1150 and 1152. The frit can be located in the sample collection device or on the collection vessel. In some embodiments, the frit is composed of materials such as but not limited to PTFE. Alternatively, some embodiments may use tape / adhesive on the needles that serve as adapter channels 1150 and 1152. In one embodiment, the tape / adhesive can be used to cover the needle opening to prevent premature discharge of the sample. Optionally, some embodiments may include adapter channels 1150 and 1152 with water-repellent surfaces to prevent controlled flow from flowing out of the adapter channel opening to the sample container. In some embodiments, the adapter channels 1150 and 1152 are needles with water-repellent materials only on the inner surface near the outlet. Optionally, the water-repellent material is only located on the outer surface near the outlet. Optionally, the water-repellent material is located on the inner and outer surfaces of the needle. Optionally, another way to prevent downward flow is to increase the surface area of the capillary by changing the profile. As a non-limiting example, some embodiments may introduce a tooth-like or finger-like structure into the capillary to increase the cross-sectional area of the capillary. Optionally, some embodiments may include fins positioned toward and / or opposite to the liquid flow in the capillary to increase the cross-sectional area of the capillary. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

單樣本採集器位置至多條通道Single sampler position to multiple channels

現請參考圖13A-13B，現將說明本文所述又一實施例。圖13A繪示樣本填充部分1320之俯視圖，其具有諸如但不限於採集孔之單個採集位置1322，兩條通道1324及1326於此處交匯，將液體抽離單個採集位置1322。可選地，一些實施例可使用Y型***通道配置，其 中從採集位置1322僅引出單條通道，經過從採集位置1322引出單條共同通道後，其***成通道1324及1326。諸如但不限於針頭、探針、管、通道、中空細長件或其他結構等為通道1324及1326提供液體連通之部件可與樣本填充部分1320之一端耦合。 13A-13B, another embodiment described herein will now be described. FIG. 13A illustrates a top view of the sample filling portion 1320, which has a single collection location 1322 such as, but not limited to, a collection hole where two channels 1324 and 1326 intersect to draw liquid away from the single collection location 1322. Alternatively, some embodiments may use a Y-shaped split channel configuration, which Only a single channel is led from the collecting position 1322, and after a single common channel is led from the collecting position 1322, it is split into channels 1324 and 1326. Components such as, but not limited to, needles, probes, tubes, channels, hollow elongated members, or other structures that provide liquid communication for the channels 1324 and 1326 may be coupled to one end of the sample filling portion 1320.

圖13B繪示側剖視圖，其中示出採集位置1322，其與通道1326成液體連通，而所述通道轉而與轉接通道1352成液體連通，所述轉接通道諸如但不限於液體連通部件。一些實施例中，所述液體連通部件可具有充足硬度，並具有充分穿刺力之尖端，以穿刺容器之隔膜、蓋或其他結構。一些實施例可具有轉接通道1352,1150等等，成為非去芯結構，以便不留下一個將無法密封容器隔膜、蓋或其他結構的孔。 13B shows a side cross-sectional view showing the acquisition location 1322 in liquid communication with the channel 1326, which in turn is in liquid communication with the transition channel 1352, such as but not limited to liquid communication components. In some embodiments, the liquid communication member may have a sufficient hardness and a tip with sufficient penetration force to penetrate the septum, cover, or other structure of the container. Some embodiments may have adapter channels 1352, 1150, etc., to become a non-coreless structure so as not to leave a hole that will not seal the container diaphragm, lid or other structure.

如圖13B所示，樣本液體可被加入或落入採集位置1322，如微滴D所示。可選地，一些實施例可直接加入或直接接觸採集位置1322以加入樣本液體。儘管本文實施例顯示僅適用單個採集位置1322，應暸解，亦可設想其他實施例，其中多條通道與共用樣本採集點耦合。作為非限制性實施例，採集裝置實施例可具有兩個採集位置1322，各自具有通向其各自採集位置之通道組。一些實施例可將圖13A-B所示共用採集點通道與圖11A-11F所示獨立通道組合。並未排除共用採集位置結構與具有獨立通道的其他結構之其他組合。 As shown in FIG. 13B, the sample liquid may be added or dropped into the collection position 1322, as shown by droplet D. Alternatively, some embodiments may directly add or directly contact the collection location 1322 to add the sample liquid. Although the embodiments herein show only a single collection location 1322, it should be understood that other embodiments are also conceivable, in which multiple channels are coupled to a common sample collection point. As a non-limiting example, an embodiment of a collection device may have two collection locations 1322, each with a channel group leading to its respective collection location. Some embodiments may combine the common acquisition point channels shown in FIGS. 13A-B with the independent channels shown in FIGS. 11A-11F. Other combinations of common acquisition location structures and other structures with independent channels are not excluded.

圖13B亦顯示，此實施例可包括一個或多個組 織穿刺部件1327，其被配置為自採集位置1322向外延伸。於一個實施例中，這使得使用者能夠將目標組織同時置於採集位置1322及傷口產生位置，以供液體樣本獲取。可選地，可佈置觸發器1323以發動組織穿刺部件。可選地，所述觸發器內置於裝置之組織介面，以便當接觸到目標組織和/或當充足壓力或接觸到位時，能夠發動裝置。所述兩個位置之重疊允許使用者採用簡化規程，成功地獲取樣本。可籍由一種或多種致動技術致動組織穿刺部件1327，諸如但不限於彈簧致動、彈簧/凸輪致動、電子致動或前述技術之單個或多個組合。應暸解，可單獨或與前述任意技術一起採用諸如但不限於真空源、組織拉伸裝置、組織接合突出件等等其他幫助方法，以改良樣本獲取。 Figure 13B also shows that this embodiment may include one or more groups The piercing member 1327 is configured to extend outward from the collection location 1322. In one embodiment, this enables the user to place the target tissue at the collection location 1322 and the wound generation location simultaneously for liquid sample acquisition. Alternatively, a trigger 1323 can be arranged to activate the tissue-piercing member. Optionally, the trigger is built into the tissue interface of the device, so that the device can be activated when it contacts the target tissue and / or when sufficient pressure or contact is in place. The overlap of the two locations allows the user to use simplified procedures to successfully obtain samples. The tissue-piercing member 1327 can be actuated by one or more actuation techniques, such as but not limited to spring actuation, spring / cam actuation, electronic actuation, or a single or multiple combination of the foregoing techniques. It should be appreciated that other assistance methods such as, but not limited to, vacuum sources, tissue stretching devices, tissue engagement protrusions, etc. may be used alone or with any of the aforementioned techniques to improve sample acquisition.

現請參考圖13C，現將說明樣本採集裝置又一實施例。此實施例顯示其中整合有樣本採集裝置1402之匣1400。係具有採集位置1322及一個或多個開口1325及1329，於位置1322完成之樣本採集可隨後於此處存取，諸如但不限於籍由吸量管管頭(未繪示)進行操作。微滴D之樣本將沿箭頭所示通向開口1325及1329之路徑行進，開口中的樣本及通向各自開口1325及1329之路徑1324和/或1326中的任何樣本均被抽吸入吸量管P中。如接近吸量管P之箭頭所示，吸量管P於至少一根軸為可移除，以便能夠將樣本液體運送至所需位置。於此實施例中，匣1400可具有複數個容置容器1410，用於試劑、清洗液體、混合區 域、保存區域等等。可選地，匣1400之一些實施例可不包括任何容置容器，或可選地，僅包括一種或兩種類型容置容器。可選地，於一些實施例中，容置容器可為吸量管管頭。可選地，於一些實施例中，容置容器為經處理因而於管頭表面(通常為管頭內表面，惟並未排除其他表面)含有試劑之吸量管管頭。可選地，匣1400之一些實施例可僅包括不帶組織穿刺部件之樣本採集裝置1402，或反之亦然。 13C, another embodiment of the sample collection device will now be described. This embodiment shows a cassette 1400 in which a sample collection device 1402 is integrated. It has a collection location 1322 and one or more openings 1325 and 1329. Sample collection completed at location 1322 can be accessed here later, such as but not limited to operation by a pipette tip (not shown). The sample of droplet D will follow the path leading to the openings 1325 and 1329 as indicated by the arrow. Tube P. As indicated by the arrow near the pipette P, the pipette P is removable on at least one axis so that the sample liquid can be transported to the desired location. In this embodiment, the cartridge 1400 may have a plurality of containing containers 1410 for reagents, cleaning liquids, and mixing areas Domain, save area, etc. Optionally, some embodiments of the cassette 1400 may not include any containing containers, or alternatively, may include only one or two types of containing containers. Optionally, in some embodiments, the containing container may be a pipette tip. Optionally, in some embodiments, the containing container is a pipette tip that has been treated to contain reagents on the surface of the tip (usually the inner surface of the tip, but other surfaces are not excluded). Alternatively, some embodiments of the cassette 1400 may only include the sample collection device 1402 without tissue-piercing components, or vice versa.

現請參考圖13D，其繪示圖13C所示實施例之側剖視圖。可選地，可包括組織穿刺部件1327，用於產生傷口，進而於位置1322採集樣本液體。 Please refer to FIG. 13D, which illustrates a side cross-sectional view of the embodiment shown in FIG. 13C. Optionally, a tissue-piercing member 1327 may be included for creating a wound, and then collecting the sample liquid at the location 1322.

圖14繪示，樣本填充部分1320可與支架1330及1340連接，以形成樣本採集裝置1300。可設有視覺窗口1312，以觀察樣本液體是否已到達所需填充程度。可包括施力部件，如彈簧1356或彈性。通道支座可將通道固定於支架上。於一個實施例中，所述支座可防止通道相對於支架滑動。可籍由壓入配合、機械固定、粘劑或其他附接技術與通道耦合。支座可選地提供彈簧等施力部件可安置於其上之支架。 FIG. 14 shows that the sample filling portion 1320 can be connected to the brackets 1330 and 1340 to form the sample collection device 1300. A visual window 1312 may be provided to observe whether the sample liquid has reached the required filling level. It may include a force-applying member, such as a spring 1356 or elastic. The channel support can fix the channel on the bracket. In one embodiment, the support can prevent the channel from sliding relative to the bracket. The channel can be coupled by press-fitting, mechanical fixation, adhesive, or other attachment techniques. The support can optionally provide a bracket on which a force-applying member such as a spring can be placed.

於一個實例中，所述配合組合可包括彈簧1356，其可施加作用力使得基座1340處於延伸狀態，而彈簧則處於其自然狀態。當基座處於其延伸狀態時，容器1346a,1346b與所述配合組合之間係提供有空間。於一些實例中，當基座1340處於其延伸狀態時，通道第二端可能 或可能不接觸容器蓋。液體連通部件1352第二端可處於不與容器內部液體連通之位置。 In one example, the mating combination may include a spring 1356, which may exert a force so that the base 1340 is in an extended state, and the spring is in its natural state. When the base is in its extended state, a space is provided between the containers 1346a, 1346b and the mating combination. In some examples, when the base 1340 is in its extended state, the second end of the channel may Or it may not touch the lid of the container. The second end of the liquid communication member 1352 may be in a position not to communicate with the liquid inside the container.

將支架1330與基座1340結合將使通道1324及1326於部件1352穿透容器蓋時，與容器1346a及1346b形成液體連通，由此抽吸樣本液體進入容器1346a及1346b。 Combining the bracket 1330 with the base 1340 causes the channels 1324 and 1326 to form liquid communication with the containers 1346a and 1346b when the component 1352 penetrates the container lid, thereby drawing sample liquid into the containers 1346a and 1346b.

容器1346a或1346b可於其中具有真空和/或負壓。當通道與真空容器形成液體連通時，樣本即可被吸入容器中。所述裝置可保持於壓縮狀態，其基座1340佈置為容器與通道1326及1328處於液體連通，與此同時樣本液體被傳遞至容器。樣本可填滿整個容器或容器之一部分。來自通道之樣本整體(和/或大於90%、95%、97%、98%、99%、99.5%或99.9%的樣本)可被傳遞至容器。或者，來自通道之樣本僅有一部分被傳遞至容器 The container 1346a or 1346b may have vacuum and / or negative pressure therein. When the channel is in liquid communication with the vacuum container, the sample can be drawn into the container. The device can be kept in a compressed state, and its base 1340 is arranged such that the container is in liquid communication with the channels 1326 and 1328, while the sample liquid is transferred to the container. The sample can fill the entire container or part of the container. The entire sample from the channel (and / or samples greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9%) can be delivered to the container. Or, only a part of the sample from the channel is transferred to the container

如圖15所示，與本文所述實施例中，向樣本採集裝置1300進行兩步樣本液體填充，可實現i)樣本液體計量採集，確保於採集通道中獲得充足液量，並經處理以防止過早凝固，及隨後ii)將高比例樣本液體傳遞入容器中之有效方式。這樣自預先填充的通道低損失地填充至容器，去計量最少量之樣本液體填充至容器1346，其具有多個優點，尤其是當處理採集小體積樣本液體時。預先填充通道至所需程度確保容器中存在足夠液量，得以對樣本液體進行所需測試。 As shown in FIG. 15, in the embodiment described herein, two-step sample liquid filling is performed on the sample collection device 1300 to achieve i) sample liquid metering collection to ensure that sufficient liquid volume is obtained in the collection channel and processed to prevent Premature coagulation, and then ii) an effective way to transfer a high proportion of sample liquid into the container. This fills the container with low loss from the pre-filled channel to meter the smallest amount of sample liquid into the container 1346, which has several advantages, especially when handling small volumes of sample liquid. Pre-fill the channel to the required degree to ensure that there is sufficient liquid in the container to perform the required test on the sample liquid.

現請參考圖16及17，現將說明又一實施例。 圖16繪示於採集位置1322周圍具有次級採集區域1324之血液採集裝置1300。所述次級採集區域1324可被用於引導任意溢出、濺出或錯誤引導之液體樣本至採集位置1322。 16 and 17 now, another embodiment will now be described. FIG. 16 shows a blood collection device 1300 with a secondary collection area 1324 around the collection location 1322. The secondary collection area 1324 can be used to guide any spilled, spilled, or misguided liquid sample to the collection location 1322.

圖17進而繪示，容器1346a及1346b可各自具有與容器1346a及1346b相關之標識符。圖17顯示，於一個非限制性實例中，標識符1600及1602可為條碼(如1維、2維或3維)、快速反應(QR)碼、圖像、形狀、文字、數字、文數字串、顏色或其任意組合或任意類型視覺標識符中至少一種。其他實施例可使用不處於可視光譜內之標識符。其他實施例可使用RFID標籤、RF標識符、IR發射標籤或其他不依賴透過可視光譜發送之信號加以識別的標誌。 FIG. 17 further illustrates that the containers 1346a and 1346b may each have identifiers associated with the containers 1346a and 1346b. Figure 17 shows that in a non-limiting example, the identifiers 1600 and 1602 can be bar codes (such as 1D, 2D or 3D), quick response (QR) codes, images, shapes, text, numbers, alphanumeric At least one of a string, a color, or any combination thereof, or any type of visual identifier. Other embodiments may use identifiers that are not in the visible spectrum. Other embodiments may use RFID tags, RF identifiers, IR emission tags, or other signs that do not rely on signals sent through the visible spectrum for identification.

標識符1600及1602可被用於識別樣本採集裝置中樣本和/或樣本類型。各容器係可具有一個或多個標識符。一些實施例亦可於容器支座上使用標識符。標識符可標誌樣本採集裝置、裝置中一個或多個單個容器，或裝置部件。於一些實例中，可運送樣本採集裝置、樣本採集裝置一部分和/或容器。於一個實例中，樣本採集裝置、樣本採集裝置一部分可籍由遞送服務公司或本文他處所述任意其他服務加以運送。可遞送樣本，以便對其進行一種或多種測試。 Identifiers 1600 and 1602 can be used to identify samples and / or sample types in the sample collection device. Each container system may have one or more identifiers. Some embodiments may also use identifiers on container supports. The identifier may identify the sample collection device, one or more individual containers in the device, or device components. In some examples, the sample collection device, a portion of the sample collection device, and / or the container may be shipped. In one example, the sample collection device, a portion of the sample collection device may be shipped by a delivery service company or any other service described elsewhere herein. Samples can be delivered for one or more tests.

係可追踪樣本身份和/或提供樣本之個人身份。可包括有關所述個人之資訊(如姓名、聯繫資訊、社 會安全號、出生日期、保險資訊、收費資訊、醫療病史)及樣本提供人之其他資訊。於一些實例中，係可追踪樣本類型(如全血、血漿、尿樣等)。亦可追踪樣本將接觸之試劑類型(如抗凝劑、標記等)。可考慮有關樣本採集之額外資訊，如採集日期和/或時間、樣本採集情形、將對樣本進行之測試類型、保險資訊、醫療記錄資訊，或任意其他資訊類型。 It can track the identity of the sample and / or provide the personal identity of the sample. May include information about the individual in question (e.g. name, contact information, social Security number, date of birth, insurance information, charging information, medical history) and other information of the sample provider. In some examples, the sample type can be tracked (such as whole blood, plasma, urine, etc.). You can also track the type of reagents (such as anticoagulant, label, etc.) that the sample will be exposed to. Additional information about sample collection may be considered, such as date and / or time of collection, sample collection situation, type of test to be performed on the sample, insurance information, medical record information, or any other type of information.

標識符可協助追踪此類資訊。標識符可與此類資訊相關聯。此類資訊可存儲於樣本採集裝置外、樣本採集裝置中，或其任意組合。於一些實例中，所述資訊可被存儲於一種或多種外部裝置中，如伺服器、電腦、資料庫或具有記憶體之任意其他裝置。於一些實例中，所述資訊可被存儲於雲計算基礎架構中。存儲有所述資訊之一種或多種資源可分佈於雲中。於一些實例中，係可提供有點對點基礎架構。所述資訊可被存儲於標識符本身之中，或與他處標識符相關聯，或其中任意組合。 Identifiers can help track such information. The identifier can be associated with such information. Such information may be stored outside the sample collection device, in the sample collection device, or any combination thereof. In some examples, the information may be stored in one or more external devices, such as a server, computer, database, or any other device with memory. In some examples, the information may be stored in the cloud computing infrastructure. One or more resources storing the information can be distributed in the cloud. In some instances, the system can provide a point-to-point infrastructure. The information may be stored in the identifier itself, or associated with the identifier elsewhere, or any combination thereof.

標識符可提供唯一識別，或具有高度可能性提供唯一識別。於一些實例中，標識符可具有可視部件。標識符可為光學可檢測。於一些實例中，標識符可透過可視光辨別。於一些實例中，標識符可為條碼(如1維、2維或3維)、快速反應(QR)碼、圖像、形狀、文字、數字、文數字串、顏色或其任意組合，或任意類型視覺標識符。 The identifier can provide unique identification, or has a high probability of providing unique identification. In some examples, the identifier may have a visual component. The identifier may be optically detectable. In some examples, the identifier can be distinguished by visible light. In some examples, the identifier may be a barcode (such as 1D, 2D or 3D), quick response (QR) code, image, shape, text, number, alphanumeric string, color or any combination thereof, or any Type visual identifier.

於其他實施例中，標識符可透過任意其他類型輻射為光學可檢測。舉例而言，標識符可透過紅外線、紫 外線或電磁光譜波長之任意其他類型為可檢測。標識符可利用無熱光，如熒光、化學發光、生物發光或任意其他類型之光發射。於一些實例中，標識符可為無線電發射機和/或接收機。標識符可為射頻識別(RFID)標籤。標識符可為任意類型之無線發射機和/或接收機。標識符可發送一個或多個電信號。於一些實例中，可與標識符一起利用GPS或其他位置相關信號。 In other embodiments, the identifier may be optically detectable through any other type of radiation. For example, the identifier can pass infrared, purple Any other type of outside line or electromagnetic spectrum wavelength is detectable. The identifier can utilize athermal light, such as fluorescence, chemiluminescence, bioluminescence, or any other type of light emission. In some examples, the identifier may be a radio transmitter and / or receiver. The identifier may be a radio frequency identification (RFID) tag. The identifier can be any type of wireless transmitter and / or receiver. The identifier can send one or more electrical signals. In some examples, GPS or other location-related signals can be utilized with the identifier.

標識符可包括音頻部件或聲音部件。標識符可發射聲音，其可被區別以唯一地識別所標誌之部件。 The identifier may include an audio component or a sound component. The identifier can emit sound, which can be distinguished to uniquely identify the marked component.

標識符可透過光學檢測裝置為可檢測。舉例而言，條碼掃描儀能夠讀取標識符。於另一實例中，攝影機(舉例而言，用於拍攝靜止圖像或視頻)或其他圖像獲取裝置能夠擷取標識符圖像，並分析所述圖像以判定相關識別。 The identifier is detectable through the optical detection device. For example, a barcode scanner can read the identifier. In another example, a camera (for example, for shooting still images or video) or other image acquisition devices can capture the identifier image and analyze the image to determine the relevant identification.

圖16及17繪示用於依據本文所述實施例之樣本採集裝置1300的標識符實例。於一個實例中，樣本採集裝置可包括基座1340，其可支持和/或容納一個或多個容器1346a,1346b。可向所述樣本採集裝置供應樣本。可透過進口1322向所述樣本採集裝置供應樣本.樣本可移動至裝置中一個或多個容器1346a,1346b。 16 and 17 illustrate examples of identifiers for the sample collection device 1300 according to embodiments described herein. In one example, the sample collection device may include a base 1340, which may support and / or house one or more containers 1346a, 1346b. The sample collection device may be supplied with samples. A sample can be supplied to the sample collection device through the inlet 1322. The sample can be moved to one or more containers 1346a, 1346b in the device.

可於樣本採集裝置上提供一個或多個標識符1600,1602。於一些實施例中，標識符可位於樣本採集裝置基座1340上。標識符可位於基座底面、基座側面，或基座之任意其他部分。於一個實例中，基座可具有平坦底 面。標識符可位於基座之平坦底面。可於基座上提供一個或多個凹痕。標識符可位於凹痕中。凹痕可位於基座底面或側面。於一些實施例中，基座可包括一個或多個凸出。標識符可位於所述凸出上。於一些實例中，可於基座外表面提供標識符。或者，標識符可位於基座內表面上。可從樣本採集裝置外檢測標識符。 One or more identifiers 1600, 1602 can be provided on the sample collection device. In some embodiments, the identifier may be located on the base 1340 of the sample collection device. The identifier may be located on the bottom of the base, the side of the base, or any other part of the base. In one example, the base may have a flat bottom surface. The identifier may be located on the flat bottom surface of the base. One or more dents can be provided on the base. The identifier can be located in the dent. The dent can be located on the bottom or side of the base. In some embodiments, the base may include one or more protrusions. The identifier may be located on the protrusion. In some examples, the identifier may be provided on the outer surface of the base. Alternatively, the identifier may be located on the inner surface of the base. The identifier can be detected from outside the sample collection device.

於一些實施例中，可於容器1346a,1346b上提供標識符。標識符可位於容器外表面或容器內表面上。可從容器外檢測標識符。於一些實施例中，可於容器底面上提供標識符。 In some embodiments, identifiers may be provided on the containers 1346a, 1346b. The identifier may be located on the outer surface of the container or the inner surface of the container. The identifier can be detected from outside the container. In some embodiments, the identifier may be provided on the bottom surface of the container.

於一個實例中，基座可包括一個光透射部分。所述光透射部分可位於基座底部或基座側面。舉例而言，可提供透明或半透明窗口。於另一個實例中，所述光透射部分可為孔，因而不需要窗口。所述光透射部分可使得基座內部一部分為可視。標識符可設於基座外表面光透射部分、基座內表面，惟其透過所述光透射部分為可視，或容器外表面或內表面，惟其透過所述光透射部分為可視。於一些實例中，可於容器內表面提供標識符，惟所述容器可為光透射，使得透過容器和/或光透射部分可觀察標識符。 In one example, the base may include a light transmitting portion. The light transmission part may be located at the bottom of the base or at the side of the base. For example, transparent or translucent windows can be provided. In another example, the light-transmitting portion may be a hole, and thus no window is required. The light transmission part may make a part of the interior of the base visible. The identifier may be provided on the light transmission part on the outer surface of the base or the inner surface of the base, but it is visible through the light transmission part, or the outer surface or the inner surface of the container, but it is visible through the light transmission part. In some examples, the identifier may be provided on the inner surface of the container, but the container may be light transmissive, so that the identifier can be viewed through the container and / or the light transmitting portion.

標識符可為QR碼或其他光學標識符，其係從樣本採集裝置外為光學可視。QR碼可透過位於樣本採集裝置基座底部之光學窗口或孔觀察。可於樣本採集裝置基座上或於透過基座可視之容器部分上提供QR碼。可於樣 本採集裝置外部提供攝影機或掃描儀等圖像獲取裝置，且其能夠讀取QR碼。 The identifier may be a QR code or other optical identifier, which is optically visible from outside the sample collection device. The QR code can be viewed through an optical window or hole at the bottom of the base of the sample collection device. The QR code can be provided on the base of the sample collection device or on the container part visible through the base. Available An image acquisition device such as a camera or a scanner is provided outside the acquisition device, and it can read QR codes.

可於樣本採集裝置上提供一個或複數個QR碼或其他標識符。於一些實例中，各容器可具有至少一個標識符，如與其相關之QR碼。於一個實例中，各容器可於基座中提供有至少一個窗口，且各窗口可允許使用者觀察QR碼或其他標識符。舉例而言，兩個容器1346a,1346b可被容納於基座1340中，其各自具有可從樣本採集裝置外識別之相關標識符1600,1602。 One or more QR codes or other identifiers can be provided on the sample collection device. In some examples, each container may have at least one identifier, such as a QR code associated with it. In one example, each container may be provided with at least one window in the base, and each window may allow the user to view the QR code or other identifier. For example, two containers 1346a, 1346b can be housed in the base 1340, each of which has a relevant identifier 1600, 1602 that can be identified from outside the sample collection device.

基座1340可從支架1330或樣本採集裝置之其他部分分離。標識符可與基座一起從樣本採集裝置其他部分分開。 The base 1340 can be detached from the holder 1330 or other part of the sample collection device. The identifier can be separated from the rest of the sample collection device together with the base.

於一些實施例中，標識符可設於基座所容納之容器。將基座從樣本採集裝置其他部分分開可導致容器與樣本採集裝置其他部分分開。容器可保留於基座中，或可從基座中取出。即便容器從基座中取出，標識符依然可保持於容器上。或者，即便容器從基座中取出，標識符依然可保持於基座上。於一些實例中，基座與容器均具有標識符，如此，容器與基座即便分開，亦可對其獨立追踪和/或匹配。 In some embodiments, the identifier may be provided in the container contained in the base. Separating the base from other parts of the sample collection device may cause the container to be separated from other parts of the sample collection device. The container may remain in the base or may be removed from the base. Even if the container is removed from the base, the identifier can remain on the container. Alternatively, even if the container is removed from the base, the identifier can still be retained on the base. In some examples, both the base and the container have identifiers, so that even if the container and the base are separated, they can be independently tracked and / or matched.

於一些實例中，可於樣本採集裝置中提供任意數目之容器。樣本容器能夠接收採集自對象之樣本。各樣本容器具有唯一標識符。所述唯一標識符係與有關樣本、對象、裝置或裝置部件之任意資訊相關聯。 In some examples, any number of containers may be provided in the sample collection device. The sample container can receive samples collected from the subject. Each sample container has a unique identifier. The unique identifier is associated with any information about the sample, object, device or device component.

於一些實例中，各容器之各標識符均可為唯一。於其他實施例中，容器上之標識符不需為唯一，惟對於裝置、對象或樣本類型可為唯一。 In some examples, each identifier of each container can be unique. In other embodiments, the identifier on the container need not be unique, but may be unique for the device, object, or sample type.

樣本採集裝置可自對象接收樣本。對象可與樣本採集裝置直接接觸或提供樣本至裝置。樣本可透過裝置移動至裝置中一個或多個容器。於一些實例中，樣本可於到達容器前經過處理。可於樣本採集裝置和/或用於傳遞樣本至容器之通道中提供一種或多種塗層或物質。或者，樣本於到達容器前不經過任何處理。於一些實施例中，樣本於容器中可能或可能不經過處理。於一些實例中，可於樣本抵達容器前或當樣本抵達容器時，對該樣本進行複數個不同類型之處理。所述處理可依預定次序進行。舉例而言，第一需要為第一處理，並於第二處理之上游執行此處理。於一些實例中，樣本於任意點均不經處理。 The sample collection device can receive samples from the subject. The subject may directly contact the sample collection device or provide a sample to the device. The sample can be moved through the device to one or more containers in the device. In some examples, the sample may be processed before reaching the container. One or more coatings or substances may be provided in the sample collection device and / or the channel used to transfer the sample to the container. Alternatively, the sample does not undergo any processing before reaching the container. In some embodiments, the sample may or may not be processed in the container. In some examples, a plurality of different types of processing may be performed on the sample before the sample reaches the container or when the sample reaches the container. The processing can be performed in a predetermined order. For example, the first need is the first process, and this process is performed upstream of the second process. In some examples, samples are not processed at any point.

於一些實施例中，樣本可為血樣。第一容器可接收全血，第二容器可接收血漿。可沿流動路徑和/或容器中提供抗凝劑。 In some embodiments, the sample may be a blood sample. The first container can receive whole blood, and the second container can receive plasma. The anticoagulant may be provided along the flow path and / or in the container.

當樣本業已提供至容器中，且容器業已密封，即可運送容器至另一位置進行樣本分析。該另一位置可為實驗室。該另一位置相對於樣本採集地點可為遠程設施。可將整個樣本採集裝置送至所述另一位置。可於樣本採集裝置上提供一個或多個標識符，其可用於識別樣本採集裝置和/或其中所容納之容器。或者，基座1340可從樣本採集裝置上移除，並與其中所容納之容器一起送至所述另一 位置。可於基座上提供一個或多個標識符，其可用於識別基座和/或其中所容納之容器。於一些實例中，容器可從基座上移除，並被送至所述另一位置。可於各容器上提供一個或多個標識符，其可用於識別所述容器。 When the sample has been provided in the container and the container is sealed, the container can be transported to another location for sample analysis. The other location may be a laboratory. The other location may be a remote facility relative to the sample collection location. The entire sample collection device can be sent to the other location. One or more identifiers may be provided on the sample collection device, which may be used to identify the sample collection device and / or the container contained therein. Alternatively, the base 1340 can be removed from the sample collection device and sent to the other together with the container contained therein position. One or more identifiers can be provided on the base, which can be used to identify the base and / or the container contained therein. In some examples, the container can be removed from the base and sent to the other location. One or more identifiers can be provided on each container, which can be used to identify the container.

可運用任意合適技術讀取所述標識符。作為非限制性實例，於一些實例中，運用光學檢測器讀取標識符，如圖像獲取裝置或條碼掃描儀。於一個實例中，圖像獲取裝置可獲取QR碼圖像。可追踪有關容器之資訊。舉例而言，當容器抵達某一位置時，標識符可經掃描，且容器抵達記錄可被保存。容器之進展和/或位置可經主動和/或被動更新。於一些實例中，需特意掃描標識符以便確定容器位置。於其他實例中，標識符可主動發射信號，其可被信號閱讀器接收。舉例而言，當標識符移動穿過建築物時，信號閱讀器可追踪標識符位置。 The identifier can be read using any suitable technique. As a non-limiting example, in some examples, an optical detector is used to read the identifier, such as an image acquisition device or a barcode scanner. In one example, the image acquisition device can acquire the QR code image. Can track information about containers. For example, when the container arrives at a certain location, the identifier can be scanned and the container arrival record can be saved. The progress and / or location of the container can be actively and / or passively updated. In some instances, the identifier needs to be scanned specifically to determine the location of the container. In other examples, the identifier may actively transmit a signal, which may be received by the signal reader. For example, as the identifier moves through the building, the signal reader can track the identifier location.

於一些實例中，讀取標識符可使得使用者能夠訪問有關標識符之額外資訊。舉例而言，使用者可運用裝置獲取標識符圖像。所述裝置或其他裝置可顯示有關樣本、對象、裝置、裝置部件之資訊或本文他處所述任意其他資訊。可包括有關將執行之測試和/或測試結果之資訊。使用者可視與標識符相關之資訊，執行後續測試或行動。舉例而言，使用者可引導容器至適當位置以便測試。於一些實例中，容器可被引導至適當位置和/或對容器內容物以無需人工介入之自動方式進行適當樣本處理(如，樣本準備、化驗、檢測、分析)。 In some instances, reading the identifier may enable the user to access additional information about the identifier. For example, the user can use the device to obtain the identifier image. The device or other device may display information about the sample, object, device, device component, or any other information described elsewhere herein. May include information about the test to be performed and / or test results. The user can perform follow-up tests or actions based on the information related to the identifier. For example, the user can guide the container to an appropriate location for testing. In some examples, the container may be directed to an appropriate location and / or the container contents may be subjected to appropriate sample processing (eg, sample preparation, testing, testing, analysis) in an automated manner without manual intervention.

有關樣本處理之資訊可經採集，並與標識符相關聯。舉例而言，如果容器具有標識符，且對容器內容物業已執行樣本處理，響應樣本處理之一個或多個信號可經存儲和/或與標識符相關聯。可以無需人工介入之自動方式完成此類更新。或者，使用者可啟動資訊存儲或可手工輸入資訊。由此，有關某一對象之醫學記錄可以自動方式聚集。標識符可被用於索引和/或存取有關對象之資訊。 Information about sample processing can be collected and associated with the identifier. For example, if the container has an identifier and sample processing has been performed on the container content property, one or more signals in response to the sample processing may be stored and / or associated with the identifier. Such updates can be done in an automated manner without manual intervention. Alternatively, the user can activate the information store or can manually enter the information. As a result, medical records related to an object can be gathered in an automated manner. The identifier can be used to index and / or access information about the object.

樣本器皿Sampleware

圖18A-18B繪示用於依據本文所述實施例之樣本採集裝置的樣本器皿1800之非限制性實例。於一些實例中，樣本器皿可由樣本採集裝置支持。可選地，樣本器皿可由樣本採集裝置一部分包含或圍繞。於一個實例中，樣本採集裝置可具有第一配置，其中樣本器皿被完全包裹。係可提供第二配置，其中樣本採集裝置可被打開，且樣本器皿至少一部分被暴露。於一些實例中，樣本器皿可由樣本採集裝置支座支持和/或至少局部暴露。所述支座可與樣本採集裝置其它部分分離，由此以便提供至其中樣本器皿之通路。 18A-18B illustrate non-limiting examples of sample vessels 1800 used in sample collection devices according to embodiments described herein. In some examples, the sample vessel may be supported by the sample collection device. Alternatively, the sample vessel may be contained or surrounded by a portion of the sample collection device. In one example, the sample collection device may have a first configuration in which the sample vessel is completely wrapped. The system may provide a second configuration in which the sample collection device can be opened and at least a portion of the sample vessel is exposed. In some examples, the sample vessel may be supported by the sample collection device holder and / or at least partially exposed. The holder can be separated from other parts of the sample collection device, thereby providing access to the sample vessel therein.

就體液採集而言，樣本液體可籍由樣本採集裝置自病患抽取，所述樣本採集裝置諸如但不限於2012年9月6日提交之美國專利申請案第61/697,797號及2013年3月15日提交之美國專利申請案第61/798,873號所說明之裝置，兩者均籍由引用合併於此以用於所有目的。於一個非限制性血樣實例中，一些實施例可透過自對象採集毛細管 血而採集血樣。這可籍由傷口、穿刺點或其他對象毛細管血獲取點而完成。可選地，亦可籍由靜脈穿刺或其他血管穿刺，獲取血樣並載入樣本器皿中，由此採集血液。舉例而言，可運用被配置為籍由靜脈穿刺採集小體積血液之裝置採集血液。舉例而言，此類裝置可包括中空針頭，其與具有小內部體積之器皿處於液體連通或能夠與其形成液體連通。該具有小內部體積之器皿可具有，例如等於或不超過5ml、4ml、3ml、2ml、1ml、750μl、500μl、400μl、300μl、200μl、100μl、90μl、80μl、70μl、60μl、50μl、40μl、30μl、20μl、10μl或5μl之內部體積。並未排除用於採集體液之其他類型裝置及技術。 For body fluid collection, the sample fluid can be drawn from the patient by a sample collection device such as, but not limited to, US Patent Application No. 61 / 697,797 filed on September 6, 2012 and March 2013 The device described in US Patent Application No. 61 / 798,873 filed on the 15th is incorporated by reference for all purposes. In a non-limiting example of a blood sample, some embodiments may collect capillaries from a subject Blood samples were collected. This can be done from wounds, puncture points or other subjects' capillary blood acquisition points. Alternatively, a blood sample can be obtained by venipuncture or other vascular puncture and loaded into a sample vessel, thereby collecting blood. For example, a device configured to collect small volumes of blood by venipuncture can be used to collect blood. For example, such a device may include a hollow needle that is in liquid communication with a vessel with a small internal volume or capable of forming liquid communication therewith. The vessel with a small internal volume may have, for example, equal to or not more than 5 ml, 4 ml, 3 ml, 2 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 100 μl, 90 μl, 80 μl, 70 μl, 60 μl, 50 μl, 40 μl, 30 μl , 20μl, 10μl or 5μl internal volume. Other types of devices and techniques for collecting body fluids are not excluded.

體液可從對象抽取，並以各種方式提供給裝置，所述方式包括但不限於手指採血、切口、注射、抽吸、棉花拭子、移量管、靜脈抽血、靜脈穿刺和/或本文他處所述任意其他技術。於一些實施例中，樣本可從對象呼吸中採集。可運用體液收集器提供體液。體液收集器可包括刺血針、毛細管、管、吸量管、注射器、針頭、微針、泵或本文他處所述任意其他收集器。於一些實施例中，樣本可為自對象提供之組織樣本。所述樣本可被從對象上移除或可被對象脫除。 Body fluids can be drawn from the subject and provided to the device in various ways, including but not limited to finger blood collection, incision, injection, aspiration, cotton swab, pipette, venous blood draw, venipuncture, and / or other At any other technology. In some embodiments, the sample may be collected from the subject's breath. A body fluid collector can be used to provide body fluids. The body fluid collector may include a lancet, capillary tube, tube, pipette, syringe, needle, microneedle, pump, or any other collector described elsewhere herein. In some embodiments, the sample may be a tissue sample provided from the subject. The sample can be removed from the subject or can be removed by the subject.

於一個實施例中，刺血針刺破對象皮膚，並籍由例如重力、毛細作用、抽吸、壓降或真空力提取樣本。刺血針或其他任意體液收集器可為裝置之一部分、裝置匣 之一部分、系統一部分或獨立部件。如有需要，刺血針或其他任意體液收集器可籍由多種機械、電氣、電機或其他任意習知啟動機制或此類方法之任意組合啟動。 In one embodiment, the lancet punctures the skin of the subject and extracts the sample by, for example, gravity, capillary action, suction, pressure drop, or vacuum force. The lancet or any other body fluid collector can be part of the device, device cartridge A part, a part of a system, or an independent component. If necessary, the lancet or any other body fluid collector can be activated by a variety of mechanical, electrical, motor, or any other conventional activation mechanism or any combination of such methods.

於一個實例中，對象手指(或對象身體另一部分)可被刺穿以產出體液。可籍由毛細管、吸量管、棉花拭子、滴劑或所屬技術領域中任意其他習知機制採集體液。毛細管或吸量管可與裝置和/或裝置匣分離，並可被***或附於裝置，或可為裝置和/或匣之一部分。於不需主動機制之另一個實施例中，對象可簡單地向裝置和/或匣提供體液，例如提供唾液樣本。 In one example, the subject's finger (or another part of the subject's body) can be pierced to produce body fluids. Body fluids can be collected by capillaries, pipettes, cotton swabs, drops, or any other conventional mechanism in the art. The capillary tube or pipette may be separate from the device and / or device cartridge, and may be inserted or attached to the device, or may be part of the device and / or cartridge. In another embodiment that does not require an active mechanism, the subject may simply provide bodily fluids to the device and / or cartridge, such as providing saliva samples.

可以多種方式自對象抽取體液，並提供至裝置，所述方式包括但不限於手指採血、切口、注射和/或移量管。可運用靜脈或非靜脈方法採集體液。可籍由體液收集器提供體液。體液收集器可包括刺血針、毛細管、管、吸量管、注射器、靜脈抽血或本文他處所述任意其他收集器。於一個實施例中，刺血針刺破皮膚，並籍由例如重力、毛細作用、抽吸或真空力提取樣本。刺血針可為裝置之一部分、裝置匣之一部分、系統一部分或獨立部件。如有需要，刺血針可籍由多種機械、電氣、電機或其他任意習知啟動機制或此類方法之任意組合啟動。於一個實例中，對象手指(或對象身體另一部分)可被刺穿以產出體液。對象身體另一部分實例可包括但不限於對象之手、腕、臂、軀幹、腿、腳或脖子。可籍由毛細管、吸量管或所屬技術領域中任意其他習知機制採集體液。毛細管或吸 量管可與裝置和/或匣分離，或可為裝置和/或匣之一部分。於不需主動機制之另一個實施例中，對象可簡單地向裝置和/或匣提供體液，例如提供唾液樣本。所採集體液可被置於裝置中。體液收集器可被附於裝置、可移除地附於裝置，或可與裝置分開提供。 Body fluid can be drawn from the subject and provided to the device in a variety of ways, including but not limited to finger blood collection, incision, injection, and / or pipette. Body fluids can be collected using intravenous or non-venous methods. The body fluid can be supplied by the body fluid collector. The body fluid collector may include a lancet, capillary tube, tube, pipette, syringe, venous blood draw, or any other collector described elsewhere herein. In one embodiment, the lancet punctures the skin and extracts the sample by, for example, gravity, capillary action, suction, or vacuum force. The lancet may be part of the device, part of the device cartridge, part of the system, or a separate component. If necessary, the lancet can be activated by a variety of mechanical, electrical, motor, or any other conventional starting mechanism or any combination of such methods. In one example, the subject's finger (or another part of the subject's body) can be pierced to produce body fluids. Examples of another part of the subject's body may include, but are not limited to, the subject's hand, wrist, arm, torso, leg, foot, or neck. Body fluids can be collected by capillaries, pipettes, or any other conventional mechanism in the art. Capillary or suction The measuring tube may be separate from the device and / or cassette, or may be part of the device and / or cassette. In another embodiment that does not require an active mechanism, the subject may simply provide bodily fluids to the device and / or cartridge, such as providing saliva samples. The collected body fluids can be placed in the device. The body fluid collector may be attached to the device, removably attached to the device, or may be provided separately from the device.

自對象獲取之樣本可被存儲於樣本器皿1800中。於本文所述實施例中，樣本器皿1800包括本體1810及蓋1820。於一些實例中，樣本器皿本體之至少部分由透明或半透明材料製成。當從樣本器皿外觀察時，樣本器皿本體可允許該樣本器皿本體中所提供之樣本為可視。樣本器皿本體可為光透射。樣本器皿本體可由允許電磁輻射透過之材料製成。於一些實例中，樣本器皿本體可由允許選定波長之電磁輻射透過，同時不允許其他非選定波長之電磁輻射透過之材料製成。於一些實例中，本體一部分或全部可由對選定波長之電磁輻射(諸如可見光波長)為不透明之材料製成。可選地，樣本器皿本體之一些部分可定型為提供特定光學路徑長度。可選地，樣本器皿本體之一些部分可定型為提供平坦表面(外和/或內)或其他結構，以便當樣本位於樣本器皿中時實現樣本分析。 The sample obtained from the subject may be stored in the sample vessel 1800. In the embodiments described herein, the sample vessel 1800 includes a body 1810 and a cover 1820. In some examples, at least part of the sample vessel body is made of transparent or translucent material. When viewed from outside the sample vessel, the sample vessel body may allow the sample provided in the sample vessel body to be visible. The sample vessel body may be light transmissive. The sample vessel body can be made of a material that allows electromagnetic radiation to pass through. In some examples, the sample vessel body may be made of a material that allows electromagnetic radiation of a selected wavelength to pass through while not allowing electromagnetic radiation of other non-selected wavelengths to pass through. In some examples, part or all of the body may be made of a material that is opaque to electromagnetic radiation of a selected wavelength (such as the wavelength of visible light). Alternatively, some portions of the sample vessel body can be shaped to provide a specific optical path length. Optionally, some portions of the sample vessel body may be shaped to provide a flat surface (outer and / or inner) or other structure to enable sample analysis when the sample is located in the sample vessel.

於一個實施例中，樣本器皿本體1810上係可設有開放端及封閉端。開放端可為樣本器皿1800之頂端1812，其可位於可被配置為與蓋配合之一端。封閉端可為樣本器皿之底端1814，其可位於樣本器皿相對於所述蓋之一端。於替代實施例中，底端亦可為開放端，其可籍由地 板關閉。於一些實施例中，頂端及底端剖面面積和/或形狀可為相當大程度地相同。或者，頂端剖面面積可大於底端剖面面積，或反之亦然。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 In one embodiment, the sample vessel body 1810 may be provided with an open end and a closed end. The open end can be the top end 1812 of the sample vessel 1800, which can be located at one end that can be configured to mate with the lid. The closed end may be the bottom end 1814 of the sample vessel, which may be located at one end of the sample vessel relative to the lid. In an alternative embodiment, the bottom end can also be an open end, which can be grounded The board closes. In some embodiments, the top and bottom cross-sectional areas and / or shapes may be substantially the same. Alternatively, the top cross-sectional area may be greater than the bottom cross-sectional area, or vice versa. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

於一個實施例中，樣本器皿本體可具有內表面及外表面。樣本器皿本體表面可為光滑、粗糙、有織紋、具有小面、有光澤、無光澤、具有槽、具有脊或具有任意其他特徵。樣本器皿本體表面可經處理，以提供所需光學特性。所述內表面及外表面可具有相同特性或可為不同。舉例而言，外表面可為光滑的，而內表面為粗糙的。 In one embodiment, the sample vessel body may have an inner surface and an outer surface. The surface of the sample vessel body may be smooth, rough, textured, with facets, shiny, matte, with grooves, with ridges, or with any other features. The surface of the sample vessel body can be treated to provide the desired optical characteristics. The inner surface and the outer surface may have the same characteristics or may be different. For example, the outer surface may be smooth, while the inner surface is rough.

可選地，樣本器皿本體可為管狀。於一些實例中，樣本器皿本體可具有一圓柱狀部分。於一些實例中，樣本器皿可具有圓形剖面形狀。或者，樣本器皿可具有任意其他剖面形狀，其中可包括橢圓形、三角形、四邊形(如正方形、長方形、梯形、平行四邊形)、五邊形、六邊形、八邊形或任意其它形狀。樣本器皿剖面形狀可能或可能不具有凸形和/或凹形。樣本器皿剖面形狀沿樣本器皿長度可保持不變或可變化。樣本器皿可沿本體長度具有棱鏡形狀。所述棱鏡可具有本文所述剖面形狀。 Alternatively, the sample vessel body may be tubular. In some examples, the sample vessel body may have a cylindrical portion. In some examples, the sample vessel may have a circular cross-sectional shape. Alternatively, the sample vessel may have any other cross-sectional shape, which may include ellipse, triangle, quadrangle (such as square, rectangle, trapezoid, parallelogram), pentagon, hexagon, octagon, or any other shape. The sample vessel cross-sectional shape may or may not have a convex shape and / or a concave shape. The cross-sectional shape of the sample vessel can be kept constant or variable along the length of the sample vessel. The sample vessel may have a prism shape along the length of the body. The prism may have the cross-sectional shape described herein.

可選地，樣本器皿底部1814可為平坦、錐形、圓形或其任意組合。於一些實例中，樣本器皿可具有半球形底。於其他實施例中，樣本器皿可具有帶有平坦部分之圓形底。樣本器皿可能或可能不能夠自己站立於平坦表面。 Alternatively, the sample vessel bottom 1814 may be flat, tapered, circular, or any combination thereof. In some examples, the sample vessel may have a hemispherical bottom. In other embodiments, the sample vessel may have a round bottom with a flat portion. The sample vessel may or may not be able to stand on a flat surface by itself.

於一個實施例中，樣本器皿1800大小可設為包含小體積液體樣本。於一些實施例中，樣本器皿可被配置為包含不超過約5ml、4ml、3ml、2ml、1.5mL、1mL、900uL、800uL、700uL、600uL、500uL、400uL、300uL、250uL、200uL、150uL、100uL、80uL、50uL、30uL、25uL、20uL、10uL、7uL、5uL、3uL、2uL、1uL、750nL、500nL、250nL、200nL、150nL、100nL、50nL、10nL、5nL、1nL、500pL、300pL、100pL、50pL、10pL、5pL或1pL。作為非限制性實例，樣本器皿上可具有資訊儲存單元，如圖1F及1G相關討論所述。於一個非限制性實例中，樣本器皿100可以液體形態容納小體積樣本液體，而於運送過程中並未使用吸收性材料、網、固體基質或相似材料容納樣本液體。這使得樣本液體能夠以液體形態被相當大程度地從樣本器皿中取出，而不因液體被吸收性材料或其他材料吸收損失樣本或樣本完整性。 In one embodiment, the sample vessel 1800 can be sized to contain a small volume of liquid sample. In some embodiments, the sample vessel may be configured to contain no more than about 5 ml, 4 ml, 3 ml, 2 ml, 1.5 mL, 1 mL, 900 uL, 800 uL, 700 uL, 600 uL, 500 uL, 400 uL, 300 uL, 250 uL, 200 uL, 150 uL, 100 uL , 80uL, 50uL, 30uL, 25uL, 20uL, 10uL, 7uL, 5uL, 3uL, 2uL, 1uL, 750nL, 500nL, 250nL, 200nL, 150nL, 100nL, 50nL, 10nL, 5nL, 1nL, 500pL, 300pL, 100pL, 100pL , 10pL, 5pL or 1pL. As a non-limiting example, the sample vessel may have an information storage unit, as described in the related discussion of FIGS. 1F and 1G. In a non-limiting example, the sample vessel 100 may contain a small volume of sample liquid in a liquid form, and no absorbent material, mesh, solid matrix, or similar material is used to contain the sample liquid during transportation. This allows the sample liquid to be removed from the sample vessel to a considerable extent in liquid form without loss of sample or sample integrity due to the liquid being absorbed by the absorbent material or other materials.

可選地，樣本器皿1800可被配置為包含不超過數滴血液、一滴血液或不超過一滴血液之一部分。舉例而言，樣本器皿可具有不大於其被配置包含之液體樣本體積的內部體積。具有小體積樣本器皿可有利地於小體積內儲存和/或運送大量樣本器皿。這可減少用於儲存和/或運送樣本器皿之資源。舉例而言，可要求較少儲存空間。另外，運送樣本器皿可使用較低成本和/或較少燃料。對於相同程度之執行，可運送更多數量之樣本器皿。 Alternatively, the sample vessel 1800 may be configured to contain no more than a few drops of blood, a drop of blood, or a portion of no more than one drop of blood. For example, the sample vessel may have an internal volume no greater than the volume of liquid sample it is configured to contain. Having a small volume of sample vessels can advantageously store and / or transport a large number of sample vessels in a small volume. This can reduce resources for storing and / or transporting sample vessels. For example, less storage space may be required. In addition, lower cost and / or less fuel may be used to transport sample vessels. For the same degree of execution, a larger number of sample vessels can be shipped.

於一些實施例中，樣本器皿1800可具有較短長度。舉例而言，樣本器皿長度可為不大於8cm、7cm、6cm、5cm、4cm、3.5cm、3cm、2.5cm、2cm、1.7cm、1.5cm、1.3cm、1.1cm、1cm、0.9cm、0.8cm、0.7cm、0.6cm、0.5cm、0.4cm、0.3cm、0.2cm、0.1cm、700um、500m、300um、100um、70um、50um、30um、10um、7um、5um、30um或1um。於一些實例中，樣本器皿之最大尺寸(例如長度、寬度或直徑)可為不大於8cm、7cm、6cm、5cm、4cm、3.5cm、3cm、2.5cm、2cm、1.7cm、1.5cm、1.3cm、1.1cm、1cm、0.9cm、0.8cm、0.7cm、0.6cm、0.5cm、0.4cm、0.3cm、0.2cm、0.1cm、700um、500m、300um、100um、70um、50um、30um、10um、7um、5um、30um或1um。 In some embodiments, the sample vessel 1800 may have a shorter length. For example, the length of the sample vessel can be no more than 8cm, 7cm, 6cm, 5cm, 4cm, 3.5cm, 3cm, 2.5cm, 2cm, 1.7cm, 1.5cm, 1.3cm, 1.1cm, 1cm, 0.9cm, 0.8cm , 0.7cm, 0.6cm, 0.5cm, 0.4cm, 0.3cm, 0.2cm, 0.1cm, 700um, 500m, 300um, 100um, 70um, 50um, 30um, 10um, 7um, 5um, 30um or 1um. In some examples, the maximum size (eg length, width or diameter) of the sample vessel may be no greater than 8cm, 7cm, 6cm, 5cm, 4cm, 3.5cm, 3cm, 2.5cm, 2cm, 1.7cm, 1.5cm, 1.3cm , 1.1cm, 1cm, 0.9cm, 0.8cm, 0.7cm, 0.6cm, 0.5cm, 0.4cm, 0.3cm, 0.2cm, 0.1cm, 700um, 500m, 300um, 100um, 70um, 50um, 30um, 10um, 7um , 5um, 30um or 1um.

樣本器皿1800可具有任意剖面面積。所述剖面面積可不大於約16cm²、8cm²、7cm²、6cm²、5cm²、4cm²、3.5cm²、3cm²、2.5cm²、2cm²、1.5cm²、1cm²、0.9cm²、0.8cm²、0.7cm²、0.6cm²、0.5cm²、0.4cm²、0.3cm²、0.2cm²、0.1cm²、0.07cm²、0.05cm²、0.03cm²、0.02cm²、0.01cm²、0.5cm²、0.3cm²或0.1cm²。 The sample vessel 1800 may have any cross-sectional area. The cross-sectional area may not be greater than about 16cm ² , 8cm ² , 7cm ² , 6cm ² , 5cm ² , 4cm ² , 3.5cm ² , 3cm ² , 2.5cm ² , 2cm ² , 1.5cm ² , 1cm ² , 0.9cm ² , ^{0.8cm 2, 0.7cm 2, 0.6cm 2} , 0.5cm 2, 0.4cm 2, 0.3cm 2, 0.2cm 2, 0.1cm 2, 0.07cm 2, 0.05cm 2, 0.03cm 2, 0.02cm 2, 0.01cm ² , 0.5cm ² , 0.3cm ² or 0.1cm ² .

樣本器皿1800可具有任意厚度。所述厚度沿樣本器皿長度可保持不變或可變化。於一些實例中，所述厚度可被選定和/或可變化，以便提供所需光學特性。於一 些實例中，所述厚度可為不大於5mm、3mm、2mm、1mm、700um、500um、300um、200um、150um、100um、70um、50um、30um、10um、7um、5um、3um、1um、700nm、500nm、300nm或100nm。 The sample vessel 1800 can have any thickness. The thickness may remain constant or variable along the length of the sample vessel. In some examples, the thickness may be selected and / or may be varied to provide the desired optical characteristics. Yu Yi In some examples, the thickness may be no greater than 5mm, 3mm, 2mm, 1mm, 700um, 500um, 300um, 200um, 150um, 100um, 70um, 50um, 30um, 10um, 7um, 5um, 3um, 1um, 700nm, 500nm , 300nm or 100nm.

於一個實施例中，樣本器皿1800可具有利於離心分離小體積血樣之形狀。這使得樣本器皿中所採集之樣本能夠被直接送至離心分離機，毋須將樣本液體進而傳遞至用於離心裝置之另一樣本器皿。 In one embodiment, the sample vessel 1800 may have a shape that facilitates centrifugal separation of small volume blood samples. This allows the sample collected in the sample vessel to be sent directly to the centrifuge, without the need to transfer the sample liquid to another sample vessel for the centrifugal device.

可選地，樣本器皿可包括蓋1820。蓋1820可被配置為套至樣本器皿之開放端。所述蓋可堵塞樣本器皿之開放端。所述蓋可液體密封樣本器皿。所述蓋可與樣本器皿本體形成液體密封。舉例而言，氣體和/或液體不可滲透所述蓋。或者，所述蓋可允許特定氣體和/或液體通過。於一些實例中，所述蓋可為氣體可滲透而液體不可滲透。所述蓋可為樣本不可滲透。舉例而言，全血、血清或血漿不可滲透所述蓋。 Optionally, the sample vessel may include a cover 1820. The cover 1820 can be configured to fit over the open end of the sample vessel. The lid can block the open end of the sample vessel. The lid may liquid seal the sample vessel. The cover may form a liquid seal with the sample vessel body. For example, gases and / or liquids are impermeable to the cover. Alternatively, the cover may allow certain gases and / or liquids to pass through. In some examples, the cover may be gas permeable and liquid impermeable. The cover may be impermeable to the sample. For example, whole blood, serum, or plasma is impermeable to the cap.

可選地，所述蓋可被配置為以任意方式與樣本器皿配合。舉例而言，所述蓋可與樣本器皿本體壓入配合。摩擦配合和/或過盈配合可使得所述蓋保持於本體上。於其他實例中，可提供有鎖定機制，諸如滑動機制、夾子、扣件或其他技術。於一些實例中，所述蓋和/或樣本器皿本體可帶螺紋，以實現螺絲配合。於其他實例中，可利用粘劑、焊接、軟焊或銅焊將所述蓋與樣本器皿本體 連接。所述蓋以可移除方式附於樣本器皿本體。或者，所述蓋可永久性地固定於樣本器皿本體。 Optionally, the cover can be configured to mate with the sample vessel in any manner. For example, the cover can be press-fitted with the sample vessel body. A friction fit and / or interference fit can keep the cover on the body. In other examples, a locking mechanism, such as a sliding mechanism, clip, fastener, or other technology may be provided. In some examples, the cover and / or sample vessel body may be threaded to achieve a screw fit. In other examples, the cover and the body of the sample vessel may be glued, welded, soldered or brazed connection. The cover is attached to the sample vessel body in a removable manner. Alternatively, the cover may be permanently fixed to the sample vessel body.

於一些實例中，所述蓋之一部分可配合進入樣本器皿本體之一部分中。所述蓋可與樣本器皿本體形成一個制止器。於一些實例中，樣本器皿本體之一部分可配合進入所述蓋之一部分中。所述插塞可包括可懸掛於樣本器皿本體之一部分上之唇狀結構或擱架。此唇狀結構或擱架可防止所述蓋滑入樣本器皿本體中。於一些實例中，蓋之一部分可覆蓋於樣本器皿本體之頂部和/或側部。可選地，一些實施例於器皿組合中可包括諸如蓋座等額外部件。於一個實施例中，所述蓋座之用途為維持所述蓋與樣本器皿之間的緊密密封。於一個實施例中，所述蓋座與附件、唇狀結構、凹痕或樣本器皿外面上其它附件位置配合，將所述蓋固定在位。可選地，一些實施例可將所述蓋及蓋座之功能合併於一個部件中。 In some examples, a portion of the cover may fit into a portion of the sample vessel body. The cover may form a stopper with the sample vessel body. In some examples, a portion of the sample vessel body may fit into a portion of the lid. The plug may include a lip structure or a shelf that may be suspended on a portion of the sample vessel body. This lip structure or shelf prevents the cover from sliding into the sample vessel body. In some examples, a portion of the cover may cover the top and / or sides of the sample vessel body. Optionally, some embodiments may include additional components such as lid holders in the vessel combination. In one embodiment, the purpose of the lid holder is to maintain a tight seal between the lid and the sample vessel. In one embodiment, the cover seat cooperates with attachments, lip structures, indents, or other attachment positions on the outside of the sample vessel to secure the cover in place. Optionally, some embodiments may combine the functions of the cover and the cover seat into one component.

於一些實施例中，樣本器皿本體可由剛性材料製成。舉例而言，樣本器皿本體可由聚合體製成，諸如聚丙烯、聚苯乙烯或丙烯酸。於替代實施例中，樣本器皿本體可為半剛性或柔性。樣本器皿本體可由單個整體件製成。或者，可採用多個部件。所述多個部件可由相同材料或不同材料製成。 In some embodiments, the sample vessel body may be made of rigid materials. For example, the sample vessel body can be made of a polymer, such as polypropylene, polystyrene, or acrylic. In alternative embodiments, the sample vessel body may be semi-rigid or flexible. The sample vessel body can be made from a single integral piece. Alternatively, multiple components may be used. The multiple components may be made of the same material or different materials.

可選地，樣本器皿蓋可由彈性材料或本文他處所述任意其他材料製成。於一些實例中，所述蓋可由橡膠、聚合體或任意其他柔性和/或可壓縮材料製成。或 者，所述蓋可為半剛性或剛性。樣本器皿蓋可由高摩擦材料製成。樣本器皿蓋能夠與樣本器皿本體籍由摩擦配合結合。當樣本器皿蓋與樣本器皿本體配合時，即可形成液體密封。樣本器皿本體內部可與環境空氣液體隔離。於一些實例中，所述蓋中至少一個和/或接觸所述蓋之樣本器皿本體部分可由高摩擦材料和/或可壓縮材料製成。 Alternatively, the sample vessel lid may be made of an elastic material or any other material described elsewhere herein. In some examples, the cover may be made of rubber, polymer, or any other flexible and / or compressible material. or Alternatively, the cover may be semi-rigid or rigid. The sample vessel cover can be made of high friction material. The sample vessel cover can be frictionally engaged with the sample vessel body. When the sample vessel cover and the sample vessel body cooperate, a liquid seal can be formed. The interior of the sample vessel body can be isolated from ambient air liquid. In some examples, at least one of the lids and / or the portion of the sample vessel body contacting the lid may be made of high friction material and / or compressible material.

於一個實施例中，所述蓋1820可為針頭和/或樣本器皿開放端密封配合中的套管可穿透、自密封不透氣封閉件，以便保持樣本器皿中的真空和/或密閉空氣。於一些實施例中，樣本器皿內部僅為部分真空，而不為全真空。過度真空可損壞樣本液體中血液有形成分。作為非限制性實例，所述部分真空處於約50至60%全真空範圍內。可選地，所述部分真空不超過約60%全真空。可選地，所述部分真空不超過約50%全真空。可選地，所述部分真空不超過約40%全真空。作為非限制性實例，所述部分真空處於約10%至約90%全真空範圍內，或處於約20%至約70%之間，或處於約30%至約60%全真空之間。作為非限制性實例，所述部分真空處於約10%至約60%全真空範圍內，或處於約20%至約50%之間，或處於約30%至約50%全真空之間。以此方式，經削弱的力施加於體液樣本上，進而將有關樣本完整性問題減至最少。可選地，於樣本傳遞後，所述空氣處於環境壓力。可選地，於樣本傳遞後，所述空氣處於一些部分真空。可選地，複數個樣本器皿中僅有一個處於部分真空，餘者處於較高真空程度或 全真空。 In one embodiment, the cap 1820 can be a needle and / or a cannula in the open-ended sealing fit of the sample vessel, a self-sealing, gas-tight closure to maintain vacuum and / or air tightness in the sample vessel. In some embodiments, the inside of the sample vessel is only a partial vacuum, not a full vacuum. Excessive vacuum can damage the blood components in the sample fluid. As a non-limiting example, the partial vacuum is in the range of about 50 to 60% full vacuum. Optionally, the partial vacuum does not exceed about 60% full vacuum. Optionally, the partial vacuum does not exceed about 50% full vacuum. Optionally, the partial vacuum does not exceed about 40% full vacuum. As a non-limiting example, the partial vacuum is in the range of about 10% to about 90% full vacuum, or between about 20% to about 70%, or between about 30% to about 60% full vacuum. As a non-limiting example, the partial vacuum is in the range of about 10% to about 60% full vacuum, or between about 20% to about 50%, or between about 30% to about 50% full vacuum. In this way, the weakened force is exerted on the body fluid sample, thereby minimizing sample integrity issues. Optionally, after the sample is delivered, the air is at ambient pressure. Optionally, after the sample is transferred, the air is at some partial vacuum. Optionally, only one of the plurality of sample vessels is in partial vacuum, the others are in a higher vacuum level or Full vacuum.

於一些實施例中，所述蓋1820可為封閉裝置，其一端位於樣本器皿內部，另一端位於樣本器皿外部，其中內部端具有連續密封表面，與樣本器皿接觸，外部端具有自表面延伸至封閉端之環狀套管，所述環狀套管具有第一缺口，其穿過環狀套管壁並與樣本器皿並列。於一個實施例中，所述封閉件具有圍繞內部端第一缺口而形成之凹環，所述凹環與管狀樣本器皿之***配合。 In some embodiments, the cover 1820 may be a closed device with one end inside the sample vessel and the other end outside the sample vessel, where the inner end has a continuous sealing surface in contact with the sample vessel and the outer end has a surface extending from the surface to the closure An annular sleeve at the end, the annular sleeve having a first notch that passes through the wall of the annular sleeve and is juxtaposed with the sample vessel. In one embodiment, the closure has a concave ring formed around the first notch at the inner end, the concave ring cooperating with the bulge of the tubular sample vessel.

可選地，所述蓋可由單個整體件製成。或者，可採用多個部件。所述多個部件可由相同材料或不同材料製成。所述蓋材料可與樣本器皿本體材料相同或不同。於一個實例中，樣本器皿本體可由光透射材料製成，而所述蓋則由不透明材料製成。 Alternatively, the cover may be made from a single unitary piece. Alternatively, multiple components may be used. The multiple components may be made of the same material or different materials. The cover material may be the same as or different from the material of the sample vessel body. In one example, the sample vessel body may be made of a light-transmitting material, and the cover is made of an opaque material.

可選地，所述蓋1820可以可移除方式與本體配合。所述蓋之一部分可被***本體中。所述蓋可包括唇狀結構，其可置於本體頂部。所述唇狀結構未被***本體中。於此非限制性實例中，所述唇狀結構可防止所述蓋被完全***本體中。所述唇狀結構可圍繞所述蓋形成連續凸緣。於一些實例中，所述唇狀結構之一部分可與本體一部分重疊，或覆蓋本體一部分。本體一部分可被***所述蓋之一部分中。 Optionally, the cover 1820 may be removably engaged with the body. A part of the cover may be inserted into the body. The cover may include a lip-like structure, which may be placed on top of the body. The lip structure is not inserted into the body. In this non-limiting example, the lip structure can prevent the cap from being fully inserted into the body. The lip structure may form a continuous flange around the cover. In some examples, a portion of the lip structure may overlap with or cover a portion of the body. A part of the body may be inserted into a part of the cover.

可選地，可被***本體中所述蓋部分可具有圓形底。或者，該部分可為平坦、錐形、彎曲、波狀或具有任意其他形狀。所述蓋可成型為易於被***本體中。 Alternatively, the cover portion, which may be inserted into the body, may have a round bottom. Alternatively, the portion may be flat, tapered, curved, wavy, or have any other shape. The cover may be shaped to be easily inserted into the body.

於一些實例中，可於所述蓋頂部設有凹陷。所述凹陷可跟隨可被***本體中所述蓋部分。於一些實例中，可於所述蓋內設有中空或凹陷。所述凹陷能夠接收一條通道之一部分，所述通道可被用於向樣本器皿交付樣本。所述凹陷可幫助引導所述通道至所需要的所述蓋部分。於一個實例中，於所述通道與樣本器皿內部形成液體連通前，所述通道可被置於所述凹陷中。 In some examples, a recess may be provided on the top of the cover. The recess may follow the cover portion that may be inserted into the body. In some examples, a hollow or depression may be provided in the cover. The recess can receive a portion of a channel that can be used to deliver samples to the sample vessel. The recess can help guide the channel to the desired cover portion. In one example, the channel can be placed in the recess before the channel is in liquid communication with the interior of the sample vessel.

可選地，所述通道及蓋可經共同壓制，使得所述通道穿透所述蓋並進入樣本器皿內部，由此形成所述通道與樣本器皿內部之液體連通。於一些實例中，所述蓋可具有所述通道可通過之裂縫。或者，所述通道可刺過完整蓋材料。所述通道可從樣本器皿中被抽出，由此使得所述通道與樣本器皿脫離液體連通。所述蓋能夠於所述通道被移除後再次密封。舉例而言，所述蓋可由自密封材料製成。於一些實例中，所述蓋可具有於所述通道被移除後關閉之裂縫，由此形成液體密封。 Alternatively, the channel and the cover may be co-pressed so that the channel penetrates the cover and enters the inside of the sample vessel, thereby forming liquid communication between the channel and the inside of the sample vessel. In some examples, the cover may have a slit through which the channel can pass. Alternatively, the channel can be pierced through the complete cover material. The channel can be withdrawn from the sample vessel, thereby removing the channel from the sample vessel in liquid communication. The cover can be sealed again after the channel is removed. For example, the cover may be made of self-sealing material. In some examples, the cover may have a crack that closes after the channel is removed, thereby forming a liquid seal.

於一些實施例中，本體可包括一個或多個凸緣或其他表面特徵。表面特徵實例可包括凸緣、凸起、突塊、槽、脊、螺紋、孔、小面或任意其他表面特徵。凸緣和/或其他表面特徵可環繞本體。凸緣和/或表面特徵可位於或接近本體頂部。凸緣和/或其他表面特徵可位於本體之上半部、三分之一上部、四分之一上部、五分之一上部、六分之一上部、八分之一上部或十分之一上部。所述表面特徵可用於在樣本採集裝置中支持樣本器皿。所述表 面特徵可用於從樣本採集裝置中取出樣本器皿和/或將樣本器皿定位於樣本採集裝置中。凸緣和/或其他表面特徵可能或可能不與所述蓋配合。 In some embodiments, the body may include one or more flanges or other surface features. Examples of surface features may include flanges, protrusions, bumps, grooves, ridges, threads, holes, facets, or any other surface features. The flange and / or other surface features may surround the body. The flange and / or surface features may be at or near the top of the body. The flange and / or other surface features may be located on the upper half of the body, the upper third, the upper quarter, the upper fifth, the upper sixth, the upper eighth, or the tenth Upper part. The surface features can be used to support sample vessels in a sample collection device. The table The face feature can be used to remove the sample vessel from the sample collection device and / or position the sample vessel in the sample collection device. The flange and / or other surface features may or may not mate with the cover.

可選地，所述蓋可具有相對於樣本器皿本體之任意尺寸。於一些實例中，所述蓋和/或本體可具有相似剖面面積。所述蓋可具有與本體上部相同或相當大程度相似之剖面面積和/或形狀。於一些實例中，所述蓋可具有短於本體之長度。舉例而言，所述蓋之長度可小於60%、50%、40%、30%、25%、20%、15%、10%、7%、5%、3%或1%的本體長度。 Alternatively, the cover may have any size relative to the sample vessel body. In some examples, the cover and / or body may have a similar cross-sectional area. The cover may have the same or substantially similar cross-sectional area and / or shape as the upper portion of the body. In some examples, the cover may have a shorter length than the body. For example, the length of the cover may be less than 60%, 50%, 40%, 30%, 25%, 20%, 15%, 10%, 7%, 5%, 3%, or 1% of the body length.

現請參考圖18C至18E，樣本器皿1800之又一實施例可包括蓋支座1830，其套於所述蓋上，以固定所述蓋。作為非限制性實例，蓋支座1830亦可於蓋支座1830中包括開口，其使得轉接器等部件能夠滑過並穿透所述蓋1820。圖18C繪示部件分解圖。 Referring now to FIGS. 18C to 18E, yet another embodiment of the sample vessel 1800 may include a cover holder 1830, which is sleeved on the cover to fix the cover. As a non-limiting example, the cover holder 1830 may also include an opening in the cover holder 1830, which allows components such as adapters to slide through and penetrate the cover 1820. 18C shows an exploded view of the components.

圖18D為剖視圖，其繪示樣本器皿本體1810具有被蓋支座1830覆蓋之蓋1820的實施例。如圖18D所示，蓋支座1830具有鎖定特徵1832，用於將蓋支座1830固定於樣本器皿本體1810和/或蓋1820。於一個實施例中，鎖定特徵1832包括內脊，其將與樣本器皿本體1810上的一條或多條脊1812及1814配合。圖18E繪示耦合於樣本器皿本體1810之蓋支座1830的側視圖。 FIG. 18D is a cross-sectional view illustrating an embodiment in which the sample vessel body 1810 has a cover 1820 covered by a cover support 1830. FIG. As shown in FIG. 18D, the lid holder 1830 has a locking feature 1832 for fixing the lid holder 1830 to the sample vessel body 1810 and / or lid 1820. In one embodiment, the locking feature 1832 includes an inner ridge that will mate with one or more ridges 1812 and 1814 on the sample vessel body 1810. FIG. 18E shows a side view of the lid support 1830 coupled to the sample vessel body 1810. FIG.

於一些實例中，樣本器皿(內和/或外)表面可塗覆有某種材料和/或經其處理。舉例而言，樣本器皿 內表面可塗覆有固定劑、抗體、光學塗層、抗凝劑、樣本添加劑和/或防腐劑。其可與通道中任意材料塗層相同或不同。於一個非限制性實例中，所述塗層可為但不限於聚四氟乙烯、聚二甲苯、聚山梨醇酯介面活性劑(例如聚山梨醇酯20)或其他材料，其作為表面處理減少表面張力。 In some examples, the surface of the sample vessel (inner and / or outer) may be coated with and / or treated with a certain material. For example, sample vessels The inner surface may be coated with fixatives, antibodies, optical coatings, anticoagulants, sample additives, and / or preservatives. It can be the same as or different from any material coating in the channel. In a non-limiting example, the coating may be, but is not limited to, polytetrafluoroethylene, polyxylene, polysorbate surfactant (eg polysorbate 20), or other materials, which reduce Surface Tension.

於實施例中，樣本器皿可包含血液凝固觸媒劑(例如凝血酶、矽石顆粒、玻璃顆粒)、抗糖酵解劑(例如氟化鈉)或凝膠，以促進血液細胞與血漿之分離。於實例中，樣本器皿可包含聚苯乙烯磺酸鈉(SPS)、枸橼酸鹽葡萄糖添加劑、過氯酸或檸檬酸鈉。一些實施例可包括以上各組中至少一種材料。可選地，亦應暸解，並未排除其他添加劑或材料，尤其是當所述添加劑就功能性而言並無互相干擾時。 In an embodiment, the sample vessel may contain a blood coagulation catalyst (such as thrombin, silica particles, glass particles), an anti-glycolytic agent (such as sodium fluoride), or a gel to promote the separation of blood cells from plasma . In an example, the sample vessel may contain sodium polystyrene sulfonate (SPS), citrate glucose additive, perchloric acid, or sodium citrate. Some embodiments may include at least one material from each of the above groups. Alternatively, it should also be understood that other additives or materials are not excluded, especially when the additives do not interfere with each other in terms of functionality.

可選地，所述塗層被施加於樣本器皿全部內表面。可選地，一些實施例中，塗層施加方式為僅覆蓋樣本器皿中選定區域。一些實施例可僅覆蓋樣本器皿內部區域之上部。可選地，一些實施例可僅覆蓋樣本器皿內部區域之下部。可選地，一些實施例可覆蓋樣本器皿內部區域之條帶、線條或其他幾何圖案。可選地，一些實施例亦可塗覆與樣本器皿同時使用之蓋、插塞或帽的表面。一些實施例可塗覆樣本進入樣本器皿之表面，以使樣本離開進入區域、抵達目標點之傳遞順利，所述目標點諸如但不限於容器底部。 Optionally, the coating is applied to the entire inner surface of the sample vessel. Optionally, in some embodiments, the coating is applied to cover only selected areas in the sample vessel. Some embodiments may cover only the upper part of the interior area of the sample vessel. Alternatively, some embodiments may cover only the lower part of the inner area of the sample vessel. Optionally, some embodiments may cover strips, lines, or other geometric patterns in the interior area of the sample vessel. Optionally, some embodiments may also coat the surface of the lid, plug, or cap that is used simultaneously with the sample vessel. Some embodiments may coat the surface of the sample into the sample vessel to facilitate the transfer of the sample from the entry area to the target point, such as but not limited to the bottom of the container.

可選地，所述塗層可為濕或乾塗層。一些實施 例可具有至少一層乾塗層及至少一層濕塗層。於一些實例中，可於樣本器皿內表面塗覆並乾燥一種或多種試劑。或可於潮濕環境中或籍由凝膠提供所述塗層。一些實施例可於樣本器皿中包括一種分離凝膠，從而使選定樣本部分與其他樣本部分保持分離。一些實施例可包括血清分離凝膠或血漿分離凝膠，諸如但不限於美商必帝股份有限公司供應之基於多元酯的分離凝膠。 Alternatively, the coating may be a wet or dry coating. Some implementations Examples may have at least one dry coating and at least one wet coating. In some examples, one or more reagents may be coated and dried on the inner surface of the sample vessel. Or the coating may be provided in a humid environment or by gel. Some embodiments may include a separation gel in the sample vessel to keep the selected sample portion separate from other sample portions. Some embodiments may include a serum separation gel or a plasma separation gel, such as, but not limited to, a polyester-based separation gel supplied by Merchant Corporation.

可選地，可於樣本器皿中提供一種或多種固體基體。舉例而言，可於樣本器皿中提供一種或多種微珠或顆粒。所述微珠和/或顆粒可塗覆有本文所述試劑或任意其他物質。所述微珠和/或顆粒能夠溶解於樣本中。所述微珠和/或顆粒可由一種或多種試劑製成，或可用於處理樣本。可於樣本器皿中提供氣體形態試劑。所述樣本器皿可被密封。樣本器皿可於樣本被引入樣本器皿前、樣本被引入樣本器皿後和/或樣本被引入樣本器皿過程中保持密封。於一個實施例中，樣本器皿可具有平滑表面和/或圓形底。這有助於將血樣所受壓力降至最低，尤其於離心分離過程中。當然，於替代實施例中，並未排除樣本器皿底部之其他形狀。 Alternatively, one or more solid substrates can be provided in the sample vessel. For example, one or more microbeads or particles can be provided in the sample vessel. The microbeads and / or particles may be coated with the reagents described herein or any other substances. The microbeads and / or particles can be dissolved in the sample. The microbeads and / or particles can be made from one or more reagents, or can be used to process a sample. Gaseous reagents can be provided in sample vessels. The sample vessel can be sealed. The sample vessel may remain sealed before the sample is introduced into the sample vessel, after the sample is introduced into the sample vessel, and / or during the sample is introduced into the sample vessel. In one embodiment, the sample vessel may have a smooth surface and / or a round bottom. This helps to minimize the pressure on blood samples, especially during centrifugation. Of course, in alternative embodiments, other shapes of the bottom of the sample vessel are not excluded.

於實施例中，處於密封樣本器皿中的體液樣本可於液體樣本中保留溶解氣體，諸如儲存於密封樣本器皿中的樣本可保留之溶解氣體具有與新近自對象身體中提取之體液樣本或新近自不同樣本準備之體液樣本(如，新近自全血準備之血漿)相似或相同之組成。於實施例中，處 於密封樣本器皿中的液體樣本可於10分鐘、20分鐘、30分鐘、45分鐘、1小時、2小時、4小時、6小時、8小時、12小時、16小時、24小時、48小時或72小時時段內保留溶解氣體之至少99%、98%、95%、90%、80%、70%、60%、50%、40%、30%或20%。於此類實施例中，所述時段通常起始於樣本存入樣本器皿之時或樣本器皿密封之時。為促進保留體液樣本中溶解氣體，樣本可於選定溫度，如20C、15C、10C、4C，或於低於0C之冷凍溫度儲存於密封樣本器皿中。並未排除其他樣本儲存溫度。 In an embodiment, the body fluid sample in the sealed sample vessel may retain dissolved gas in the liquid sample, such as the sample stored in the sealed sample vessel may retain dissolved gas having a body fluid sample recently extracted from the subject's body or newly Samples of body fluid prepared from different samples (eg, plasma prepared from whole blood recently) have similar or identical composition. In the embodiment, Liquid samples in sealed sample vessels can be used for 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours or 72 At least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% of dissolved gas is retained during the hour period. In such embodiments, the time period generally begins when the sample is stored in the sample vessel or when the sample vessel is sealed. To facilitate the retention of dissolved gases in body fluid samples, samples can be stored in sealed sample vessels at selected temperatures, such as 20C, 15C, 10C, 4C, or at freezing temperatures below 0C. The storage temperature of other samples is not excluded.

同樣地，於實施例中，處於密封樣本器皿中的體液樣本可於液體樣本中保留溶解分析物，諸如儲存於密封樣本器皿中的樣本可保留之分析物具有與新近自對象身體中提取之體液樣本或新近自不同樣本準備之體液樣本(如，新近自全血準備之血漿)相似或相同之組成。於實施例中，處於密封樣本器皿中的液體樣本可於10分鐘、20分鐘、30分鐘、45分鐘、1小時、2小時、4小時、6小時、8小時、12小時、16小時、24小時或48小時時段內保留分析物之至少99%、98%、95%、90%、80%、70%、60%、50%、40%、30%或20%。於此類實施例中，所述時段通常起始於樣本存入樣本器皿之時或樣本器皿密封之時。為促進保留體液樣本中一種或多種分析物，樣本可於選定溫度，如20C、15C、10C、4C，或於低於0C之冷凍溫度儲存於密封樣本器皿中。並未排除 其他樣本儲存溫度。可選地，可於樣本被引入器皿後離心分離樣本器皿。舉例而言，可於樣本被引入器皿後30秒、1分鐘、2分鐘、3分鐘、4分鐘、5分鐘、10分鐘、15分鐘、20分鐘、30分鐘、45分鐘、1小時、2小時、4小時、8小時、24小時、2天、3天、4天、5天、7天或10天內離心分離樣本器皿。離心分離包含有例如全血樣本等樣本之樣本器皿，係促進血液細胞與血漿之分離，進而生成血漿及細胞團。於一些情形中，離心分離樣本係提高血液或血漿中一種或多種分析物之穩定性。 Similarly, in an embodiment, the body fluid sample in the sealed sample vessel may retain dissolved analyte in the liquid sample, such as the sample stored in the sealed sample vessel may retain the analyte with the body fluid recently extracted from the subject's body The samples or body fluid samples newly prepared from different samples (eg, plasma prepared recently from whole blood) are of similar or identical composition. In an embodiment, the liquid sample in the sealed sample vessel can be used for 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 24 hours Or at least 99%, 98%, 95%, 90%, 80%, 70%, 60%, 50%, 40%, 30% or 20% of the analyte is retained for a 48-hour period. In such embodiments, the time period generally begins when the sample is stored in the sample vessel or when the sample vessel is sealed. To facilitate retention of one or more analytes in the body fluid sample, the sample can be stored in a sealed sample vessel at a selected temperature, such as 20C, 15C, 10C, 4C, or at a freezing temperature below 0C. Not excluded Storage temperature of other samples. Alternatively, the sample vessel can be centrifuged after the sample is introduced into the vessel. For example, 30 seconds, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours after the sample is introduced into the vessel Centrifuge the sample vessel within 4 hours, 8 hours, 24 hours, 2 days, 3 days, 4 days, 5 days, 7 days or 10 days. Centrifugal separation of sample vessels containing samples such as whole blood samples promotes the separation of blood cells and plasma, thereby generating plasma and cell mass. In some cases, centrifuging the sample increases the stability of one or more analytes in blood or plasma.

圖18F亦繪示，樣本器皿可各自具有至少一個與所述樣本器皿相關之資訊儲存單元。可選地，一些實施例可具有一個資訊儲存單元傳送有關複數個樣本器皿之資訊，尤其(然非排他地)於所有樣本器皿均包含採自同一對象之樣本的情形中。此類資訊儲存單元可置於容納多個樣本器皿之載體上，而不置於樣本器皿本身之上。 FIG. 18F also shows that the sample vessels may each have at least one information storage unit related to the sample vessel. Alternatively, some embodiments may have an information storage unit to transmit information about a plurality of sample vessels, especially (but not exclusively) in the case where all sample vessels contain samples taken from the same subject. Such an information storage unit can be placed on a carrier holding a plurality of sample vessels, rather than on the sample vessels themselves.

圖18F繪示樣本器皿之一的底面仰視圖，其顯示，於一個非限制性實例中，所述資訊儲存單元1860可為條碼(如1維、2維或3維)、快速反應(QR)碼、圖像、形狀、文字、數字、文數字串、顏色或其任意組合或任意類型視覺資訊儲存單元中至少一種。其他實施例可使用不處於可視光譜內之資訊儲存單元。其他實施例可使用RFID標籤、RF資訊儲存單元、IR發射標籤或其他不依賴透過可視光譜發送之信號加以識別的標誌。當然，資訊儲存單元1860亦可被置於樣本器皿頂端表面。圖18G繪示， 可選地，資訊儲存單元1860亦可被設置與樣本器皿側面上，其可為額外添加於或替代位於頂部或底部之資訊儲存單元1860。 18F shows a bottom view of one of the sample vessels, which shows that, in a non-limiting example, the information storage unit 1860 can be a barcode (such as 1D, 2D, or 3D), fast response (QR) At least one of a code, image, shape, text, number, alphanumeric string, color, or any combination thereof or any type of visual information storage unit. Other embodiments may use information storage units that are not in the visible spectrum. Other embodiments may use RFID tags, RF information storage units, IR emission tags, or other signs that do not rely on signals sent through the visible spectrum for identification. Of course, the information storage unit 1860 can also be placed on the top surface of the sample vessel. Figure 18G shows, Optionally, the information storage unit 1860 can also be provided on the side of the sample vessel, which can be additionally added to or replace the information storage unit 1860 at the top or bottom.

於一個非限制性實例中，資訊儲存單元1860可被用於識別樣本採集裝置中的樣本和/或樣本類型。可選地，各樣本器皿係可具有一個或多個資訊儲存單元。一些實施例亦可於樣本器皿支座上使用資訊儲存單元。資訊儲存單元可識別樣本採集裝置、裝置中一個或多個單個樣本器皿，或裝置部件。於一些實例中，可運送樣本採集裝置、樣本採集裝置一部分和/或樣本器皿。於一個實例中，樣本採集裝置或樣本採集裝置一部分可籍由遞送服務公司或本文他處所述任意其他服務加以運送。可遞送樣本器皿，以便對樣本進行一種或多種測試。 In one non-limiting example, the information storage unit 1860 may be used to identify samples and / or sample types in the sample collection device. Optionally, each sample vessel may have one or more information storage units. Some embodiments may also use the information storage unit on the sample vessel holder. The information storage unit can identify the sample collection device, one or more individual sample vessels in the device, or device components. In some examples, the sample collection device, a portion of the sample collection device, and / or the sample vessel may be shipped. In one example, the sample collection device or part of the sample collection device may be shipped by a delivery service company or any other service described elsewhere herein. The sample vessel can be delivered to perform one or more tests on the sample.

可選地，係可追踪樣本身份和/或提供樣本之個人身份。作為非限制性實例，可包括有關所述個人之資訊(如姓名、聯繫資訊、社會安全號、出生日期、保險資訊、收費資訊、醫療病史)及樣本提供人之其他資訊。於一些實例中，係可追踪樣本類型(如全血、血漿、尿樣等)。可選地，亦可追踪樣本將接觸之試劑類型(如抗凝劑、標記等)。可考慮有關樣本採集之額外資訊，如採集日期和/或時間、樣本採集情形、將對樣本進行之測試類型、測試設置、測試規程、保險資訊、醫療記錄資訊，或任意其他資訊類型。 Alternatively, the identity of the sample can be tracked and / or the personal identity of the sample provided. As non-limiting examples, information about the individual (such as name, contact information, social security number, date of birth, insurance information, fee information, medical history) and other information about the sample provider can be included. In some examples, the sample type can be tracked (such as whole blood, plasma, urine, etc.). Optionally, the type of reagent (eg anticoagulant, label, etc.) to which the sample will be exposed can also be tracked. Additional information about sample collection may be considered, such as the date and / or time of collection, the sample collection situation, the type of test to be performed on the sample, test settings, test procedures, insurance information, medical record information, or any other type of information.

於本文所述至少一個或多個實施例中，資訊儲 存單元可協助追踪此類資訊。資訊儲存單元可與此類資訊相關聯。此類資訊可存儲於樣本採集裝置外、樣本採集裝置中，或其任意組合。於一些實例中，所述資訊可被存儲於一種或多種外部裝置中，如伺服器、電腦、資料庫或具有記憶體之任意其他裝置。於一些實例中，所述資訊可被存儲於雲計算基礎架構中。存儲有所述資訊之一種或多種資源可分佈於雲中、自遠程伺服器分佈於互聯網路、無線鏈接於遠程電腦處理器等等。於一些實例中，係可提供有點對點基礎架構。所述資訊可被存儲於資訊儲存單元本身之中，或與他處資訊儲存單元相關聯，或其中任意組合。 In at least one or more embodiments described herein, the information store The storage unit can help track such information. The information storage unit can be associated with such information. Such information may be stored outside the sample collection device, in the sample collection device, or any combination thereof. In some examples, the information may be stored in one or more external devices, such as a server, computer, database, or any other device with memory. In some examples, the information may be stored in the cloud computing infrastructure. One or more resources storing the information can be distributed in the cloud, distributed from the remote server to the Internet, wirelessly linked to the remote computer processor, and so on. In some instances, the system can provide a point-to-point infrastructure. The information can be stored in the information storage unit itself, or associated with other information storage units, or any combination thereof.

可選地，資訊儲存單元可提供唯一識別，或具有高度可能性提供唯一識別。於一些實例中，資訊儲存單元可具有可視部件。資訊儲存單元可為光學可檢測。於一些實例中，資訊儲存單元可透過可視光辨別。於一些實例中，資訊儲存單元可為條碼(如1維、2維或3維)、快速反應(QR)碼、圖像、形狀、文字、數字、文數字串、顏色或其任意組合，或任意類型視覺資訊儲存單元。 Alternatively, the information storage unit may provide unique identification, or have a high possibility to provide unique identification. In some examples, the information storage unit may have visual components. The information storage unit may be optically detectable. In some examples, the information storage unit can be identified by visible light. In some examples, the information storage unit may be a barcode (such as 1D, 2D, or 3D), quick response (QR) code, image, shape, text, number, alphanumeric string, color, or any combination thereof, or Any type of visual information storage unit.

於其他實施例中，資訊儲存單元可透過任意其他類型輻射為光學可檢測。舉例而言，資訊儲存單元可透過紅外線、紫外線或電磁光譜波長之任意其他類型為可檢測。資訊儲存單元可利用無熱光，如熒光、化學發光、生物發光或任意其他類型之光發射。於一些實例中，資訊儲存單元可為無線電發射機和/或接收機。資訊儲存單元可為射頻識別(RFID)標籤。資訊儲存單元可為任意類型 之無線發射機和/或接收機。資訊儲存單元可發送一個或多個電信號。於一些實例中，可與資訊儲存單元一起利用GPS或其他位置相關信號。 In other embodiments, the information storage unit can be optically detectable through any other type of radiation. For example, the information storage unit may be detectable through infrared, ultraviolet, or any other type of electromagnetic spectrum wavelength. The information storage unit can utilize athermal light, such as fluorescence, chemiluminescence, bioluminescence, or any other type of light emission. In some examples, the information storage unit may be a radio transmitter and / or receiver. The information storage unit may be a radio frequency identification (RFID) tag. Information storage unit can be any type Wireless transmitter and / or receiver. The information storage unit can send one or more electrical signals. In some examples, GPS or other location-related signals can be used with the information storage unit.

可選地，資訊儲存單元可為和/或包括音頻部件或聲音部件。資訊儲存單元可發射聲音，其可被區別以唯一地識別所標誌之部件。 Alternatively, the information storage unit may be and / or include an audio component or a sound component. The information storage unit can emit sound, which can be distinguished to uniquely identify the marked parts.

可選地，資訊儲存單元可透過光學檢測裝置為可檢測。舉例而言，條碼掃描儀能夠讀取資訊儲存單元。於另一實例中，攝影機(舉例而言，用於拍攝靜止圖像或視頻)或其他圖像獲取裝置能夠擷取資訊儲存單元圖像，並分析所述圖像以判定相關識別。 Alternatively, the information storage unit may be detectable through the optical detection device. For example, the barcode scanner can read the information storage unit. In another example, a camera (for example, used to capture still images or video) or other image acquisition devices can capture the image of the information storage unit and analyze the image to determine the relevant identification.

可選地，資訊儲存單元可位於樣本器皿支座上。可於支座中提供一個或多個凹痕。資訊儲存單元可位於凹痕中。凹痕可位於支座底面或側面。於一些實施例中，支座可包括一個或多個凸出。資訊儲存單元可位於所述凸出上。於一些實例中，可於支座外表面提供資訊儲存單元。或者，資訊儲存單元可位於支座內表面上。可從樣本採集裝置外檢測資訊儲存單元。 Alternatively, the information storage unit may be located on the sample vessel support. One or more indentations can be provided in the support. The information storage unit may be located in the dent. The dent can be located on the bottom or side of the support. In some embodiments, the support may include one or more protrusions. The information storage unit may be located on the protrusion. In some examples, an information storage unit may be provided on the outer surface of the support. Alternatively, the information storage unit may be located on the inner surface of the support. The information storage unit can be tested from outside the sample collection device.

於一些實施例中，資訊儲存單元可位於樣本器皿外表面或樣本器皿內表面上。可從樣本器皿外檢測資訊儲存單元。於一些實施例中，可於樣本器皿底面上提供資訊儲存單元。 In some embodiments, the information storage unit may be located on the outer surface of the sample vessel or the inner surface of the sample vessel. The information storage unit can be tested from outside the sample vessel. In some embodiments, an information storage unit may be provided on the bottom surface of the sample vessel.

於一個非限制性實例中，支座可包括一個光透射部分。所述光透射部分可位於支座底部或支座側面。舉 例而言，可提供透明或半透明窗口。於另一個實例中，所述光透射部分可為孔，因而不需要窗口。所述光透射部分可使得支座內部一部分為可視。資訊儲存單元可設於支座外表面光透射部分、支座內表面，惟其透過所述光透射部分為可視，或樣本器皿外表面或內表面，惟其透過所述光透射部分為可視。於一些實例中，可於樣本器皿內表面提供資訊儲存單元，惟所述樣本器皿可為光透射，使得透過樣本器皿和/或光透射部分可觀察資訊儲存單元。 In a non-limiting example, the support may include a light transmitting portion. The light transmission part may be located at the bottom of the support or at the side of the support. Lift For example, transparent or translucent windows can be provided. In another example, the light-transmitting portion may be a hole, and thus no window is required. The light transmitting part may make a part of the interior of the support visible. The information storage unit may be provided on the light transmission part of the outer surface of the support and the inner surface of the support, but it is visible through the light transmission part, or the outer surface or the inner surface of the sample vessel, but is visible through the light transmission part. In some examples, an information storage unit may be provided on the inner surface of the sample vessel, but the sample vessel may be light transmissive, so that the information storage unit can be observed through the sample vessel and / or the light transmissive portion.

可選地，資訊儲存單元可為QR碼、條碼或其他光學資訊儲存單元，其係光學可視，諸如但不限於從樣本採集裝置外為可視。QR碼可透過位於樣本採集裝置支座底部之光學窗口或孔等等觀察。可於樣本採集裝置支座上或於透過支座可視之樣本器皿的一部分上提供QR碼。可於樣本器皿或運送容器外部提供攝影機或掃描儀等圖像獲取裝置，且其能夠讀取QR碼。 Alternatively, the information storage unit may be a QR code, a barcode, or other optical information storage unit, which is optically visible, such as but not limited to being visible from outside the sample collection device. The QR code can be viewed through an optical window or hole at the bottom of the sample collection device support. The QR code can be provided on the support of the sample collection device or on a part of the sample vessel visible through the support. An image acquisition device such as a camera or a scanner can be provided outside the sample vessel or shipping container, and it can read QR codes.

於一些實施例中，可於樣本採集裝置上提供一個或複數個QR碼或其他資訊儲存單元。於一些實例中，各樣本器皿可具有至少一個資訊儲存單元，如與其相關之QR碼。於一個實例中，各樣本器皿可於支座中提供有至少一個窗口，且各窗口可允許使用者觀察QR碼或其他資訊儲存單元。舉例而言，兩個樣本器皿可被容納於支座中，各樣本器皿具有可從支座外識別之相關資訊儲存單元。 In some embodiments, one or more QR codes or other information storage units may be provided on the sample collection device. In some examples, each sample vessel may have at least one information storage unit, such as a QR code associated with it. In one example, each sample vessel may be provided with at least one window in the holder, and each window may allow the user to observe the QR code or other information storage unit. For example, two sample vessels can be accommodated in the holder, and each sample vessel has a related information storage unit that can be identified from outside the holder.

於一些實施例中，資訊儲存單元可設於支座所 容納之樣本器皿。將支座從樣本採集裝置其他部分分開可導致樣本器皿與樣本採集裝置其他部分分開。樣本器皿可保留於支座中，或可從支座中取出。即便樣本器皿從支座中取出，資訊儲存單元依然可保持於樣本器皿上。或者，即便樣本器皿從支座中取出，資訊儲存單元依然可保持於支座上。於一些實例中，支座與樣本器皿均具有資訊儲存單元，如此，樣本器皿與支座即便分開，亦可對其獨立追踪和/或匹配。 In some embodiments, the information storage unit may be installed in the support The sample container. Separating the support from other parts of the sample collection device may cause the sample vessel to be separated from other parts of the sample collection device. The sample vessel can be retained in the holder or can be removed from the holder. Even if the sample vessel is removed from the holder, the information storage unit can still be kept on the sample vessel. Or, even if the sample vessel is removed from the holder, the information storage unit can still be held on the holder. In some examples, both the holder and the sample vessel have an information storage unit, so that even if the sample vessel and the holder are separated, they can be independently tracked and / or matched.

於一些實例中，可於樣本採集裝置中提供任意數目之樣本器皿。一些實施例可將所有這些樣本器皿同時與樣本採集裝置連接。可選地，樣本器皿可以依序或其他非同時方式耦合。樣本器皿能夠接收採集自對象之樣本。各樣本器皿可選地具有唯一資訊儲存單元。所述唯一資訊儲存單元係與有關樣本、對象、裝置或裝置部件之任意資訊相關聯。 In some examples, any number of sample vessels can be provided in the sample collection device. Some embodiments may connect all these sample vessels to the sample collection device at the same time. Alternatively, the sample vessels can be coupled in a sequential or other non-simultaneous manner. The sample vessel can receive samples collected from the subject. Each sample vessel optionally has a unique information storage unit. The unique information storage unit is associated with any information about samples, objects, devices, or device parts.

於一些實例中，各樣本器皿之各資訊儲存單元均可為唯一或包含唯一資訊。於其他實施例中，樣本器皿上之資訊儲存單元不需為唯一。可選地，一些實施例可具有唯一於裝置、對象和/或樣本類型的資訊。於一些實施例中，資訊儲存單元中的資訊可被用於將數個樣本器皿與同一對象或同一資訊相關聯。 In some examples, each information storage unit of each sample vessel may be unique or contain unique information. In other embodiments, the information storage unit on the sample vessel need not be unique. Alternatively, some embodiments may have information unique to the device, object, and / or sample type. In some embodiments, the information in the information storage unit can be used to associate several sample vessels with the same object or the same information.

於一些實施例中，資訊儲存單元依採集約定被附於或以其他方式與樣本器皿或樣本器皿組關聯(物理或籍由非物理關聯，如資料庫指針或鏈接)。如果按組關 聯，所述關聯可基於來自同一使用者之全部或本文所述其他因子。可選地，一些實施例可早已於樣本器皿或樣本器皿組上設有資訊儲存單元。於一個非限制性實例中，資訊儲存單元提供標識符資訊，其隨後於或接近樣本採集之時，與對象關聯。於此實例中，資訊儲存單元之資訊保持不變，然其隨後與對象相連。於另一實施例中，資訊儲存單元之資訊被更改，以包括有關對象之資訊。可選地，兩者可同時發生於一些實施例中，其中某些資訊被更改，某些不被更改(惟其隨後可與對象或與有關採集事件的資訊，如時間日期等，相關聯)。 In some embodiments, the information storage unit is attached to or otherwise associated with the sample vessel or sample vessel group (physical or non-physical association, such as database pointer or link) according to the collection convention. If you close by group The association may be based on all factors from the same user or other factors described herein. Optionally, some embodiments may already have an information storage unit on the sample vessel or sample vessel group. In one non-limiting example, the information storage unit provides identifier information, which is then associated with the object at or near the time of sample collection. In this example, the information of the information storage unit remains unchanged, but then it is connected to the object. In another embodiment, the information of the information storage unit is modified to include information about the object. Alternatively, both may occur in some embodiments at the same time, where some of the information is changed and some is not changed (but it may then be associated with the object or with information about the collection event, such as time and date, etc.).

現請參考圖19A至19C，現將說明樣本採集裝置前端之各種實施例。圖19A繪示具有用於各自通道之開口1103及1105的樣本採集裝置前端視圖。於此實施例中，開口1103及1105被置於彼此很相近之處，開口1103及1105兩者之間為分隔壁1910。於一個非限制性實例中，分隔壁1910厚度被設為，可籍由用於製成樣本採集裝置之製造流程加以可靠製造的最小厚度。於一個實施例中，壁厚應為約1-10mm。於一些實施例中，開口1103及1105可為使得所述開口兩者彼此很相近之上下配置、對角配置或其他配置，而不為並列佈置。 19A to 19C, various embodiments of the front end of the sample collection device will now be described. 19A shows a front view of a sample collection device with openings 1103 and 1105 for the respective channels. In this embodiment, the openings 1103 and 1105 are placed in close proximity to each other, and between the openings 1103 and 1105 is a partition wall 1910. In one non-limiting example, the thickness of the partition wall 1910 is set to the minimum thickness that can be reliably manufactured by the manufacturing process used to make the sample collection device. In one embodiment, the wall thickness should be about 1-10 mm. In some embodiments, the openings 1103 and 1105 may be in an up-down configuration, a diagonal configuration, or other configurations such that the openings are close to each other, rather than being arranged side by side.

現請參考圖19B，此實施例顯示開口1910及1912被配置為彼此同軸。開口1910及1912之此同軸配置使得所述開口兩者之間具有更大重疊。 Referring now to FIG. 19B, this embodiment shows that the openings 1910 and 1912 are configured to be coaxial with each other. This coaxial configuration of openings 1910 and 1912 allows for greater overlap between the openings.

現請參考圖19C，此實施例與圖19B實施例相 似，惟所述開口1920及1922為圓形，而不是正方形。應暸解，可採用任一種形狀，包括但不限於圓形、橢圓形、三角形、四邊形(如正方形、長方形、梯形)、五邊形、六邊形、八邊形或任意其它剖面形狀。當然，應暸解，各開口可採用不同形狀，且採集裝置無需為所有開口採用相同剖面形狀。一些實施例可為開口採用某種剖面形狀，然為處於開口下游之通道採用一種不同的剖面形狀。 Now refer to FIG. 19C, this embodiment is similar to the embodiment of FIG. 19B It seems that the openings 1920 and 1922 are circular instead of square. It should be understood that any shape may be used, including but not limited to a circle, ellipse, triangle, quadrangle (such as square, rectangle, trapezoid), pentagon, hexagon, octagon or any other cross-sectional shape. Of course, it should be understood that each opening may adopt a different shape, and the collection device need not use the same cross-sectional shape for all openings. Some embodiments may use a certain cross-sectional shape for the opening, but a different cross-sectional shape for the channel downstream of the opening.

單通道樣本採集裝置Single channel sample collection device

現請參考圖20A-20B，儘管本文中實施例通常說明為具有兩條單獨通道之樣本採集裝置，應暸解，一些實施例可採用單入口通道2010。所述單入口通道2010可能或可能不經塗覆。適當塗層包括但不限於抗凝劑、血漿或其他材料。 Referring now to FIGS. 20A-20B, although the embodiments herein are generally described as a sample collection device with two separate channels, it should be understood that some embodiments may use a single inlet channel 2010. The single inlet channel 2010 may or may not be coated. Suitable coatings include but are not limited to anticoagulants, plasma or other materials.

圖20A顯示，於此樣本採集裝置2000之實施例中，組織穿刺部件2112可於單入口路徑2010中同軸安裝。這使得目標組織傷口以與單入口路徑2010對齊之方式形成。組織穿刺部件2112可籍由多種技術之一啟動，諸如但不限於經按壓觸發器致動、經裝置前端接觸目標組織致動或當裝置以充足壓力抵壓目標組織時籍由壓力啟動。致動後，組織穿刺部件2012可保留於單入口路徑2010中。可選地，組織穿刺部件2012可自單入口路徑2010中縮回。 FIG. 20A shows that in this embodiment of the sample collection device 2000, the tissue-piercing member 2112 can be coaxially installed in the single entry path 2010. This allows the target tissue wound to be formed in alignment with the single entry path 2010. The tissue-piercing component 2112 can be activated by one of a variety of techniques, such as, but not limited to, activation by pressing a trigger, activation by contacting the target tissue with the front end of the device, or activation by pressure when the device presses the target tissue with sufficient pressure. After actuation, the tissue-piercing member 2012 may remain in the single entry path 2010. Alternatively, the tissue-piercing member 2012 may be retracted from the single entry path 2010.

進入樣本採集裝置2000之樣本液體可自所述單入口路徑2010分開進入兩條或更多條單獨路徑2014及 2016。這使得樣本液體能夠從採自單接觸點之樣本分開為至少兩部分。所述兩部分可選地被容納於兩個單獨容置室2018及2020中。所述室可各自具有一條或多條轉接通道2022及2024，以傳遞樣本液體至容器中，諸如但不限於容器1146a及1146b。應暸解，容置室2018及2020和/或容器1146a及1146b可於其中包含抗凝劑，以準備樣本液體用於處理。 The sample liquid entering the sample collection device 2000 can be separated from the single inlet path 2010 into two or more separate paths 2014 and 2016. This allows the sample liquid to be separated into at least two parts from the sample taken from a single contact point. The two parts are optionally accommodated in two separate accommodation chambers 2018 and 2020. The chambers may each have one or more adapter channels 2022 and 2024 to transfer sample liquid into containers, such as but not limited to containers 1146a and 1146b. It should be appreciated that the containment chambers 2018 and 2020 and / or the containers 1146a and 1146b may contain anticoagulants therein to prepare the sample liquid for processing.

現請參考圖20B，此實施例顯示其中具有組織穿刺部件2012之單入口路徑2010，其於致動後被配置為全部或部分保留於單入口路徑2010中。應暸解，此實施例可使用實心穿刺部件或具有內腔之中空穿刺部件。 Referring now to FIG. 20B, this embodiment shows a single-entry path 2010 having a tissue-piercing member 2012, which is configured to remain fully or partially in the single-entry path 2010 after actuation. It should be understood that this embodiment may use a solid piercing member or a hollow piercing member having a lumen.

現請參考圖21，現將說明樣本採集裝置2030之又一實施例。此實施例顯示縮短長度之單入口路徑2032，其具有配置為自路徑2032向外延伸之組織穿刺部件2012。於致動後，組織穿刺部件2012可處於路徑2032中，或可選地，可縮回從而不在路徑2032中。進入樣本採集裝置2030之樣本液體可自所述單入口路徑2032分開進入兩條或更多條單獨路徑2034及2036。這使得樣本液體能夠從採自單接觸點之樣本分開為至少兩部分。此實施例顯示路徑2034及2036保持毛細管通道配置，並未如圖20A-20B之實施例所示，擴大成為室。應暸解，本文中任意實施例均可包括一個或多個填充指示器用於裝置上之採集路徑和/或容器，以便使用者能夠了解何時達到充足填充程度。 Referring now to FIG. 21, another embodiment of the sample collection device 2030 will now be described. This embodiment shows a single entrance path 2032 of reduced length having a tissue-piercing member 2012 configured to extend outward from the path 2032. After actuation, the tissue-piercing member 2012 may be in the path 2032, or alternatively, may be retracted so as not to be in the path 2032. The sample liquid entering the sample collection device 2030 can separate from the single inlet path 2032 into two or more separate paths 2034 and 2036. This allows the sample liquid to be separated into at least two parts from the sample taken from a single contact point. This embodiment shows that the paths 2034 and 2036 maintain the capillary channel configuration, and are not expanded into a chamber as shown in the embodiment of FIGS. 20A-20B. It should be understood that any of the embodiments herein may include one or more filling indicators for the collection path and / or container on the device, so that the user can know when a sufficient filling level is reached.

亦應暸解，因運用諸如但不限於容器1146a及1146b等容器採集之小樣本體積，諸如但不限於真空壓力等所減少之壓力導致容器中的“拉力”被傳遞入對象身體的方式對採集樣本液體所用血管或其他內腔的破壞或使其產生不利變形為最低，或該拉力不以此種方式被傳遞入對象身體中。舉例而言，小兒及年老病患通常具有較小和/或較弱靜脈，其於採用習用、大體積vacutainer時，因與抽取大樣本體積進入習用容器相關之較高真空力會破裂。於裝置至少一個實施例中，此問題將不會發生，因為所述裝置不傳遞真空(抽吸)力至靜脈。於一個實施例中，真空力數值抽取不超過120uL樣本液體進入容器1146a中。可選地，該真空力數值抽取不超過100uL樣本液體進入容器1146a中。可選地，該真空力數值抽取不超過80uL樣本液體進入容器1146a中。可選地，該真空力數值抽取不超過60uL樣本液體進入容器1146a中。可選地，該真空力數值抽取不超過40uL樣本液體進入容器1146a中。可選地，該真空力數值抽取不超過20uL樣本液體進入容器1146a中。於一個實施例中，此種抽取類型未經使用注射器，主要基於容器之拉力及流離對象之液體的任意力即可完成。可選地，用於抽取已到達裝置內部樣本的穿過裝置之成型路徑可幫助減少自容器1146a及1146b傳遞至對象血管或其他身體內腔的力。一些實施例可於上列小體積容器中運用約四分之三或更少真空，以將樣本溶血降至最低，並防止對象中血管破裂。一些實施例可於上列小體積 容器中運用約一半或更少真空，以將樣本溶血降至最低，並防止對象中血管破裂。一些實施例可於上列小體積容器中運用約四分之一或更少真空，以將樣本溶血降至最低，並防止對象中血管破裂。本文所述真空為相對於大氣壓之全真空。 It should also be understood that due to the small sample volume collected by containers such as but not limited to containers 1146a and 1146b, the reduced pressure such as but not limited to vacuum pressure causes the "pull" in the container to be transferred into the subject's body The destruction of the blood vessel or other lumen used by the liquid or its unfavorable deformation is minimized, or the pulling force is not transmitted into the subject's body in this way. For example, pediatric and elderly patients often have smaller and / or weaker veins, which when using conventional, large-volume vacuumers, can rupture due to the higher vacuum forces associated with drawing large sample volumes into conventional containers. In at least one embodiment of the device, this problem will not occur because the device does not transmit vacuum (suction) force to the vein. In one embodiment, the vacuum force value draws no more than 120 uL of sample liquid into the container 1146a. Optionally, the vacuum force value draws no more than 100 uL of sample liquid into the container 1146a. Optionally, the vacuum force numerical extraction does not exceed 80 uL of sample liquid into the container 1146a. Optionally, the vacuum force value draws no more than 60 uL of sample liquid into the container 1146a. Optionally, the vacuum force value draws no more than 40 uL of sample liquid into the container 1146a. Optionally, the vacuum force value draws no more than 20 uL of sample liquid into the container 1146a. In one embodiment, this type of extraction is performed without using a syringe, which is mainly based on the pulling force of the container and the arbitrary force of the liquid flowing away from the object. Alternatively, the forming path through the device used to draw samples that have reached the inside of the device can help reduce the force transmitted from the containers 1146a and 1146b to the subject's blood vessel or other body lumen. Some embodiments may use about three quarters or less of vacuum in the small volume containers listed above to minimize sample hemolysis and prevent rupture of blood vessels in the subject. Some embodiments can be listed in the small volume Approximately half or less of vacuum is used in the container to minimize hemolysis of the sample and prevent rupture of blood vessels in the subject. Some embodiments may use about a quarter or less vacuum in the small volume containers listed above to minimize sample hemolysis and prevent rupture of blood vessels in the subject. The vacuum described herein is a full vacuum relative to atmospheric pressure.

亦應暸解，於一個實施例中，裝置中所述室剖面面積大於用於從對象抽取體液之針頭和/或柔性管之剖面直徑。這進一步幫助減少傳遞至對象的力。被來自容器之真空拉力最直接抽吸者為裝置中液體樣本，離對象較近位於針頭中的樣本不會被直接抽取。較長路徑，加之採集裝置中較大體積之室提供的緩衝，使施加於對象血管上之拉力變弱。另外，相較於亦處於真空狀態之較大體積器皿，小體積器皿中的初始峰值拉力大幅度地較小。所述“抽拉”歷時亦較長，使得較大量樣本進入容器中。於較小量時，需採集之樣本相當大部分已於裝置中，於開始樣本抽取動作前，還未處於裝置中而需從對象抽取之量已較少。 It should also be understood that in one embodiment, the cross-sectional area of the chamber in the device is greater than the cross-sectional diameter of the needle and / or flexible tube used to draw body fluids from the subject. This further helps reduce the force transmitted to the subject. The most directly sucked by the vacuum pull from the container is the liquid sample in the device, and the sample located in the needle closer to the object will not be directly drawn. The longer path, combined with the buffer provided by the larger volume chamber in the collection device, weakens the tensile force exerted on the subject's blood vessel. In addition, the initial peak pull in the small volume vessel is significantly smaller compared to the larger volume vessel that is also under vacuum. The "pulling" time is also longer, allowing a larger amount of sample to enter the container. At a relatively small amount, a large part of the sample to be collected is already in the device. Before the sample extraction operation is started, the amount to be drawn from the subject is not yet in the device.

現請參考圖22，現將說明樣本採集裝置之又一實施例。此實施例繪示採集裝置2100，其具有諸如但不限於Luer連接器等連接器2102，其可實現與諸如組織穿刺部件、針頭等多種樣本獲取裝置的連接。一些Luer連接器可運用壓入配合與其他連接器配合，而連接器2102的一些實施例可包括螺紋，以促進配合。圖22繪示，於此實施例中，蝶形針頭2104與液體連接路徑2106耦合，所述路徑 諸如但不限於通向連接器2108之柔性管，以連接樣本獲取特徵至樣本採集裝置2100。所述柔性管2106使針頭部分2104能位於離開樣本採集裝置2100之處，然依舊與其可***作地液體耦合。就針頭2104定位以獲取樣本液體而言，這可實現更大靈活性，不須同時移動樣本採集裝置2100。可選地，一些實施例可不經採用柔性管而直接將組織穿刺部件耦合於裝置2100。 Referring now to FIG. 22, another embodiment of the sample collection device will now be described. This embodiment illustrates a collection device 2100 having a connector 2102 such as, but not limited to, a Luer connector, which can be connected to various sample acquisition devices such as tissue-piercing components, needles, and the like. Some Luer connectors may use press-fit to mate with other connectors, while some embodiments of the connector 2102 may include threads to facilitate mating. FIG. 22 shows that in this embodiment, the butterfly needle 2104 is coupled to the liquid connection path 2106, and the path A flexible tube such as, but not limited to, a connector 2108 to connect the sample acquisition feature to the sample collection device 2100. The flexible tube 2106 enables the needle portion 2104 to be located away from the sample collection device 2100, yet still operatively fluidly coupled to it. With regard to the positioning of the needle 2104 to obtain the sample liquid, this can achieve greater flexibility without moving the sample collection device 2100 at the same time. Alternatively, some embodiments may directly couple the tissue-piercing member to the device 2100 without using a flexible tube.

所述實施例中至少一些或全部均可具有填充指示器，諸如但不限於觀察窗口或開口，其顯示樣本何時出現於採集裝置中，並由此指示可與樣本器皿接合。可選地，並未排除不具有填充指示器之實施例。一些實施例可選地包括一個或多個排氣口，諸如但不限於端口，使得空氣於採集裝置中的通道被樣本填滿時能夠排出。於多數實施例中，當所需填充程度達到後，已填滿之樣本器皿可從樣本採集裝置上分離。可選地，額外樣本器皿可與樣本採集裝置接合，以採集額外數量之體液樣本。可選地，樣本器皿之內部條件使得所述器皿具有經降低壓力配置，以僅抽入預定量之樣本液體。 At least some or all of the described embodiments may have a fill indicator, such as, but not limited to, a viewing window or opening, which shows when the sample appears in the collection device and thus indicates that it can be engaged with the sample vessel. Optionally, embodiments without fill indicators are not excluded. Some embodiments optionally include one or more exhaust ports, such as but not limited to ports, so that air can be exhausted when the channel in the collection device is filled with the sample. In most embodiments, when the required filling level is reached, the filled sample vessel can be separated from the sample collection device. Optionally, additional sample vessels can be engaged with the sample collection device to collect an additional number of body fluid samples. Optionally, the internal conditions of the sample vessel are such that the vessel has a reduced pressure configuration to draw in only a predetermined amount of sample liquid.

圖23繪示樣本採集裝置2100之實施例的分解視圖。於此非限制性實例中，部分1130可被配置為容置容器支座1140，以及具有採樣裝置支座2160之部分。所述裝置2100可包括防洩漏裝置2162，其可與轉接通道2022及2024開放端接合，以將通過開放端之樣本損失降至最低，直至支座1140中容器被接合以抽取其中任意容器中的 樣本為止。於此實施例中，防洩漏裝置2162覆蓋至少兩條轉接通道2022及2024，並被配置為可移動。防洩漏裝置2162的此實施例尺寸設置為，其可被移動，以暴露轉接通道2022及2024上的開口，同時依然使轉接通道2022及2024與支座1140中容器接合。 FIG. 23 shows an exploded view of an embodiment of the sample collection device 2100. FIG. In this non-limiting example, the portion 1130 may be configured to accommodate the container support 1140, and the portion having the sampling device support 2160. The device 2100 can include a leak prevention device 2162 that can be engaged with the open ends of the transition channels 2022 and 2024 to minimize sample loss through the open end until the container in the holder 1140 is engaged to extract any of the containers of Sample. In this embodiment, the anti-leakage device 2162 covers at least two transition channels 2022 and 2024, and is configured to be movable. This embodiment of the anti-leakage device 2162 is sized such that it can be moved to expose the openings in the adapter channels 2022 and 2024 while still engaging the adapter channels 2022 and 2024 with the container in the holder 1140.

現請參考圖24及25，其更詳細地繪示採樣裝置支座2160之實施例。圖24繪示採樣裝置支座2160為組合單位。圖25繪示具有第一部分2164及第二部分2166之採樣裝置支座2160的分解視圖。轉接通道2022及2024亦經繪示為從第二部分2166移除。儘管採樣裝置支座2160的該實施例被繪示為兩個單獨部分，應暸解，一些替代實施例可將採樣裝置支座2160配置為單個整體單位。可選地，一些實施例可配置具有超過兩個部分，其經組合形成支座2160。可選地，一些實施例可沿支座2160之縱軸2165或其他軸，而不是沿支座2160之橫軸，生成單獨部分，如圖25所示分離。 Now refer to FIGS. 24 and 25, which illustrate an embodiment of the sampling device support 2160 in more detail. FIG. 24 shows the sampling device support 2160 as a combined unit. FIG. 25 shows an exploded view of a sampling device support 2160 having a first part 2164 and a second part 2166. FIG. The transition channels 2022 and 2024 are also shown removed from the second portion 2166. Although this embodiment of the sampling device support 2160 is shown as two separate parts, it should be understood that some alternative embodiments may configure the sampling device support 2160 as a single integral unit. Optionally, some embodiments may be configured with more than two parts, which are combined to form a support 2160. Alternatively, some embodiments may create separate parts along the longitudinal axis 2165 or other axis of the support 2160, rather than along the lateral axis of the support 2160, as shown in FIG.

現請參考圖26至28，其繪示樣本裝置支座2160及裝置2100實施例之各種剖視圖。圖26繪示部分2164及2166之剖視圖。儘管其並無特定理論約束，分隔部分2164及2166可被選用於精簡製造，尤其是形成支座2160中不同內部通道及室之製造。舉例而言，所述室之至少一個壁2167可於第一部分2164中形成，而所述室之互補壁2168可於第二部分2166中形成.圖27繪示部分2166之俯視端視圖，壁2168於端視圖中可視。 Now please refer to FIGS. 26 to 28, which illustrate various cross-sectional views of the sample device holder 2160 and the device 2100 embodiment. 26 shows a cross-sectional view of portions 2164 and 2166. Although it is not bound by specific theory, the partitions 2164 and 2166 can be selected for streamlined manufacturing, especially the manufacturing of different internal channels and chambers forming the support 2160. For example, at least one wall 2167 of the chamber can be formed in the first portion 2164, and the complementary wall 2168 of the chamber can be formed in the second portion 2166. FIG. 27 shows a top end view of the portion 2166, the wall 2168 Visible in end view.

現請參考圖28，現將說明組合裝置2100之剖視圖。圖28顯示，透過連接器2102進入裝置之樣本將於通向轉接通道2022及2024前進入共同室2170。支座1140沿箭頭2172所示方向自轉接通道2022及2024起之移動將可***作地使容器1146a及1146b與轉接通道2022及2024液體耦合，將樣本自通道移至容器中。於本實施例中，係具有充分空間2174，使得容器1146a及1146b之移動促成轉接通道2022及2024穿透容器1146a及1146b之蓋，由此轉接通道2022及2024與容器1146a及1146b內部處於液體連通。儘管圖示僅有兩組容器及轉接通道，應暸解，可設置具有更多或更少容器及轉接通道組的其他配置，以用於圖28所示裝置。 Referring now to FIG. 28, a cross-sectional view of the combination device 2100 will now be described. FIG. 28 shows that the sample entering the device through the connector 2102 will enter the common chamber 2170 before leading to the transition channels 2022 and 2024. The movement of the support 1140 from the transition channels 2022 and 2024 in the direction indicated by arrow 2172 will be operable to fluidly couple the containers 1146a and 1146b and the transition channels 2022 and 2024 to move the sample from the channel into the container. In this embodiment, there is sufficient space 2174 so that the movement of the containers 1146a and 1146b causes the transition channels 2022 and 2024 to penetrate the covers of the containers 1146a and 1146b, whereby the transition channels 2022 and 2024 and the containers 1146a and 1146b Liquid communication. Although the illustration shows only two sets of containers and transition channels, it should be understood that other configurations with more or fewer containers and transition channel groups can be provided for the device shown in FIG. 28.

模組化樣本採集裝置Modular sample collection device

現請參考圖29A-29C，儘管本文所述實施例將樣本採集裝置說明為具有轉接通道，將樣本採集通道與容器相連，應暸解，並未排除不具有此種配置之實施例。 Referring now to FIGS. 29A-29C, although the embodiments described herein illustrate the sample collection device as having an adapter channel, connecting the sample collection channel to the container, it should be understood that embodiments that do not have such a configuration are not excluded.

如圖29A之非限制性實例繪示，如本文上文所述，一些實施例可不具有分開、單獨的轉接通道。本文中，採集通道2422與容器2446可籍由所述元件之一或兩者之間如箭頭2449所示之相對運動而直接相連。 As shown in the non-limiting example of FIG. 29A, as described herein above, some embodiments may not have separate, separate transition channels. Here, the collection channel 2422 and the container 2446 may be directly connected by relative movement between one or both of the elements as shown by arrow 2449.

如圖29B之非限制性實例繪示，一條或多條轉接通道2454可為最初與採集通道2422或容器2446皆不直接液體連通之分開元件。本文中，採集通道2422可籍由採集通道、轉接通道2454或容器2446(依序或同時)之一 或更多者間的相對運動而與容器2446相連，以產生自採集通道通過一條或多條轉接通道進入容器之液體路徑。 As shown in the non-limiting example of FIG. 29B, one or more transition channels 2454 may be separate elements that are not in direct liquid communication with either the collection channel 2422 or the container 2446 initially. In this article, the collection channel 2422 may be one of the collection channel, the transfer channel 2454 or the container 2446 (sequentially or simultaneously) The relative movement between the two or more is connected to the container 2446 to create a liquid path from the collection channel into the container through one or more transfer channels.

如圖29C之非限制性實例繪示，一條或多條轉接通道2454可為最初與容器2446接觸之元件。轉接通道2454可不與所述內部或容器直接相通。本文中，採集通道2400可籍由這些元件(依序或同時)之一或更多者間的相對運動而與容器相連，以產生自採集通道通過一條或多條轉接通道進入容器之液體路徑。一些實施例可具有隔膜、套管、帶排氣口之套管或置於採集通道末端之上的蓋2455，其將與轉接通道接合。所述各種元件之接合亦可將轉接通道2454移入容器2446內部，如最初一般，轉接通道2454可與所述內部不處於液體連通。本文中一些實施例可具有更多轉接通道，且一些實施例可採用通道兩端均為尖銳端之轉接通道。可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。 As shown in the non-limiting example of FIG. 29C, one or more transition channels 2454 may be the elements that initially contact the container 2446. The transfer channel 2454 may not directly communicate with the interior or the container. In this article, the collection channel 2400 may be connected to the container by relative motion between one or more of these elements (sequentially or simultaneously) to create a liquid path from the collection channel into the container through one or more transition channels . Some embodiments may have a septum, cannula, cannula with vent, or cover 2455 placed over the end of the collection channel, which will engage the transition channel. The joining of the various elements can also move the transition channel 2454 into the interior of the container 2446. As usual, the transition channel 2454 may not be in liquid communication with the interior. Some embodiments herein may have more transition channels, and some embodiments may use transition channels with sharp ends at both ends of the channel. Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions.

應暸解，本文中任意實施例均可經修改以包括圖29A-29C所示特徵。 It should be understood that any of the embodiments herein can be modified to include the features shown in FIGS. 29A-29C.

樣本處理Sample processing

現請參考圖30，現將說明體液樣本採集及運送系統實施例。圖30繪示位於對象皮膚表面S上的一個體液樣本B。於圖30之非限制性實例中，體液樣本B可籍由多種裝置之一加以採集。作為非限制性實例，採集裝置1530可為但不限於2012年9月6日提交之美國專利申請案第61/697,797號所述之裝置，其籍由引用合併於此以用於所 有目的。於此實施例中，體液樣本B係透過一條或多條毛細通道得以採集，並隨後引導至樣本器皿1540。作為非限制性實例，至少一個樣本器皿1540內部可具有最初處於用於抽取體液樣本進入樣本器皿1540之部分真空。一些實施例可同時自樣本採集裝置中相同或不同採集通道抽取樣本採集裝置中的樣本進入樣本器皿1540中。可選地，一些實施例可同時抽取樣本進入樣本器皿中。 Referring now to FIG. 30, an embodiment of a body fluid sample collection and delivery system will now be described. FIG. 30 shows a body fluid sample B on the skin surface S of the subject. In the non-limiting example of FIG. 30, the body fluid sample B can be collected by one of various devices. As a non-limiting example, the collection device 1530 may be, but not limited to, the device described in US Patent Application No. 61 / 697,797 filed on September 6, 2012, which is incorporated herein by reference for all purposes Purposeful. In this embodiment, the body fluid sample B is collected through one or more capillary channels and then guided to the sample vessel 1540. As a non-limiting example, the interior of the at least one sample vessel 1540 may have a partial vacuum initially for drawing a bodily fluid sample into the sample vessel 1540. Some embodiments may simultaneously draw samples from the sample collection device into the sample vessel 1540 from the same or different collection channels in the sample collection device. Alternatively, some embodiments may draw samples into the sample vessel at the same time.

於本實施例中，當體液樣本處於樣本器皿1540中後，位於其支座1542(或可選地，從其支座1542移除)之樣本器皿1540被載入運送容器1500。於本實施例中，係設有一條或多條槽，其尺寸大小適宜樣本器皿支座1542或適宜於運送容器1500中的樣本器皿槽。作為非限制性實例，其可以陣列構架容置樣本器皿，並定位成垂直或一些其他預定定位。應暸解，樣本器皿1540的一些實施例被配置為於各器皿中容置不同量之樣本。作為非限制性實例，可基於各樣本器皿中的真空力值、採集裝置之樣本採集通道中所採集樣本量和/或其他因子對此加以控制。可選地，諸如但不限於不同抗凝劑或類似物等各種前處理亦可存在於樣本器皿中。 In this embodiment, after the body fluid sample is in the sample vessel 1540, the sample vessel 1540 located on its support 1542 (or optionally removed from its support 1542) is loaded into the transport container 1500. In this embodiment, one or more slots are provided, the size of which is suitable for the sample vessel support 1542 or the sample vessel slot in the transport container 1500. As a non-limiting example, it may house sample vessels in an array frame and be positioned vertically or some other predetermined location. It should be appreciated that some embodiments of the sample vessel 1540 are configured to contain different amounts of sample in each vessel. As a non-limiting example, this can be controlled based on the vacuum force value in each sample vessel, the sample volume collected in the sample collection channel of the collection device, and / or other factors. Optionally, various pretreatments such as but not limited to different anticoagulants or the like may also be present in the sample vessel.

如圖30所示，樣本器皿1540於諸如但不限於樣本採集地點的第一位置採集樣本。作為非限制性實例，體液樣本隨後於運送容器1500中被運送至第二位置，諸如但不限於接收地點，諸如但不限於分析地點。運送方法可為快件、郵件遞送或其它運送技術。於很多實施例中，可 籍由容納運送容器於其中的另一容器完成所述運送。於一個實施例中，樣本採集地點可為護理點。可選地，樣本採集地點可為服務點。可選地，樣本採集地點可為遠離樣本分析地點。 As shown in FIG. 30, the sample vessel 1540 collects samples at a first location such as but not limited to a sample collection location. As a non-limiting example, the body fluid sample is then transported in the transport container 1500 to a second location, such as but not limited to a receiving location, such as but not limited to an analysis location. The shipping method may be express, mail delivery, or other shipping technologies. In many embodiments, The transportation is completed by another container containing the transportation container therein. In one embodiment, the sample collection location may be a point of care. Alternatively, the sample collection location may be a service point. Alternatively, the sample collection location may be remote from the sample analysis location.

儘管圖30之本實施例繪示體液樣本採自對象表面，其他替代實施例可運用採集技術自對象其他區域採集樣本，如靜脈穿刺，進而裝滿樣本器皿1540。並不排除此類其他採集技術作為表面採集之替代或與其共同使用。表面採集可位於對象之外表面。可選地，一些實施例可自對象內部之易進入表面採集。這些表面上體液樣本B之存在可為自然產生或可透過產生傷口或其他使體液表面可進入的技術。 Although this embodiment of FIG. 30 shows that the body fluid sample is taken from the surface of the subject, other alternative embodiments may use a collection technique to collect samples from other areas of the subject, such as venipuncture, and then fill the sample vessel 1540. It is not excluded that such other collection techniques are used as an alternative to or in conjunction with surface collection. Surface acquisition can be located on the surface outside the object. Alternatively, some embodiments may collect from a surface easily accessible inside the object. The presence of the body fluid sample B on these surfaces may be naturally occurring or permeable to create wounds or other techniques to make the body fluid surface accessible.

現請參考圖31，其繪示另一實施例，其中相對於採集聚於對象表面之樣本，體液樣本可從對象內部採集。圖31實施例繪示採集裝置1550，其具有配置為採集包括但不限於靜脈血液等體液樣本之皮下注射針頭1552。於一個實施例中，體液樣本可填充裝置1550中室1554，其時樣本器皿1540可被接合，以抽取樣本進入各自器皿中。可選地，一些實施例可不具有室1554，與之相反，除用於自針頭1552引導樣本至樣本器皿1540之通道、路徑或管外，具有極小空間。對於諸如血液等體液樣本，血液器皿中壓力可為，血樣並不需要採集裝置提供幫助即可填滿室1554。此類實施例可選地包括一個或多個排氣口，諸如但不限於端口，使得空氣於採集裝置中通道被樣本填滿 時能夠。可選地，一些實施例可具有直接附於採集裝置1550之針頭，而不是管道連接至針頭，類似圖44所示，其中針頭為剛性或相當大程度剛性地與採集裝置相連。一些實施例可具有可移除連接、可釋放連接、Luer連接、螺紋連接或可於將來開發之其他針頭連接技術。 Referring now to FIG. 31, it illustrates another embodiment in which a body fluid sample can be collected from inside the object relative to the sample collected on the surface of the object. The embodiment of FIG. 31 illustrates a collection device 1550 having a hypodermic needle 1552 configured to collect samples of bodily fluids including but not limited to venous blood. In one embodiment, the body fluid sample may fill the middle chamber 1554 of the device 1550, at which time the sample vessel 1540 may be engaged to draw the sample into the respective vessel. Optionally, some embodiments may not have the chamber 1554, in contrast, with minimal space except for the channels, paths, or tubes used to guide the sample from the needle 1552 to the sample vessel 1540. For body fluid samples such as blood, the pressure in the blood vessel may be such that the blood sample can fill the chamber 1554 without assistance from the collection device. Such embodiments optionally include one or more exhaust ports, such as but not limited to ports, such that the passage of air in the collection device is filled with the sample Can. Alternatively, some embodiments may have a needle attached directly to the collection device 1550 instead of a tube connected to the needle, similar to that shown in Figure 44, where the needle is rigid or rather rigidly connected to the collection device. Some embodiments may have removable connections, releasable connections, Luer connections, threaded connections, or other needle connection technologies that may be developed in the future.

所述實施例中至少一些或全部均可具有填充指示器，諸如但不限於觀察窗口或開口，其顯示樣本何時出現於採集裝置中，並由此指示可與樣本器皿1540接合。可選地，並未排除不具有填充指示器之實施例。當所需填充程度達到後，已填滿之樣本器皿1540可從樣本採集裝置上分離。可選地，額外樣本器皿1540可與樣本採集裝置1550(或1530)接合，以採集額外數量之體液樣本。 At least some or all of the described embodiments may have a fill indicator, such as, but not limited to, a viewing window or opening, which shows when the sample appears in the collection device, and thus indicates that it can be engaged with the sample vessel 1540. Optionally, embodiments without fill indicators are not excluded. When the required filling level is reached, the filled sample vessel 1540 can be separated from the sample collection device. Alternatively, the additional sample vessel 1540 may be engaged with the sample collection device 1550 (or 1530) to collect an additional number of body fluid samples.

服務點系統Service Point System

現請參考圖32，應暸解，本文所述處理可籍由自動技術完成。所述自動處理可用於一體化之自動系統。於一些實施例中，此可為處於其中具有複數個功能性部件且由共同外殼圍繞之單個儀器中。用於沈澱之處理技術及方法可為預設。可選地，此可基於按美國專利申請案第13/355,458號及第13/244,947號中所述方式根據需要動態變化之規程或程序，該兩者籍由引用合併於此以用於所有目的。 Referring now to FIG. 32, it should be understood that the processing described in this article can be accomplished by automated techniques. The automatic processing can be used in an integrated automatic system. In some embodiments, this may be in a single instrument having multiple functional components therein and surrounded by a common housing. The treatment technique and method used for precipitation can be preset. Alternatively, this may be based on procedures or procedures that dynamically change as needed in the manner described in US Patent Application Nos. 13 / 355,458 and 13 / 244,947, which are hereby incorporated by reference for all purposes .

於圖32所示非限制性實例中，一體化儀器2500可設有可程式處理器2502，其可被用於控制儀器之複數個部件。舉例而言，於一個實施例中，處理器2502可 控制單個或多個吸量管系統2504，其沿箭頭2506及2508所示X-Y及Z方向為可移動。相同或不同處理器亦可控制儀器中其他部件2512,2514或2516。於一個實施例中，部件2512,2514或2516其中之一包括離心分離機。 In the non-limiting example shown in FIG. 32, the integrated instrument 2500 may be provided with a programmable processor 2502, which may be used to control a plurality of components of the instrument. For example, in one embodiment, the processor 2502 may A single or multiple pipette system 2504 is controlled, which is movable in the X-Y and Z directions shown by arrows 2506 and 2508. The same or different processors can also control other parts 2512, 2514 or 2516 in the instrument. In one embodiment, one of the components 2512, 2514 or 2516 includes a centrifuge.

如圖32所示，處理器2502之控制可允許吸量管系統2504自匣2510獲取血樣，並將樣本移至部件2512,2514或2516之一。此移動可包括將樣本分配至匣2510中可移除器皿，隨後將所述可移除器皿運送至部件2512,2514或2516之一。可選地，血樣可被直接分配入已安裝於部件2512,2514或2516之一上的容器中。於一個非限制性實例中，這些部件2512,2514或2516之一可為離心分離機，其具有成像配置以對容器中樣本進行照明及可視展示。其他部件2512,2514或2516執行其他分析、化驗或檢測功能。 As shown in FIG. 32, the control of the processor 2502 may allow the pipette system 2504 to take a blood sample from the cassette 2510 and move the sample to one of the components 2512, 2514, or 2516. This movement may include dispensing the sample into a removable vessel in the cassette 2510 and then transporting the removable vessel to one of the components 2512, 2514, or 2516. Alternatively, the blood sample can be dispensed directly into a container that has been mounted on one of the components 2512, 2514, or 2516. In one non-limiting example, one of these components 2512, 2514, or 2516 may be a centrifuge, which has an imaging configuration to illuminate and visually display the sample in the container. Other components 2512, 2514, or 2516 perform other analysis, testing, or detection functions.

前述全部內容皆可被整合於單個外殼2520中，並被配置用於台式或小佔地面積之地板安裝。於一個實例中，小佔地面積地板安裝系統可佔有約4m²或更少之地面面積。於一個實例中，小佔地面積地板安裝系統可佔有約3m²或更少之地面面積。於一個實例中，小佔地面積地板安裝系統可佔有約2m²或更少之地面面積。於一個實例中，小佔地面積地板安裝系統可佔有約1m²或更少之地面面積。於一些實施例中，該儀器佔地面積可為小於或等於約4m²、3m²、2.5m²、2m²、1.5m²、1m²、0.75m²、0.5m²、0.3m²、0.2m²、0.1m²、0.08m²、0.05 m²、0.03m²、100cm²、80cm²、70cm²、60cm²、50cm²、40cm²、30cm²、20cm²、15cm²或10cm²。一些處於服務點環境中之合適系統於美國專利申請案第13/355,458號及第13/244,947號中所述，該兩者籍由引用合併於此以用於所有目的。此實施例可經配置為用於所引用專利申請中所述任意模組或系統。 All of the foregoing can be integrated into a single housing 2520 and configured for desktop or floor installation with a small footprint. In one example, a small floor space installation system can occupy about 4 m ² or less of floor space. In one example, a small floor space installation system can occupy about 3 m ² or less of floor space. In one example, a small floor space installation system can occupy about 2 m ² or less of floor space. In one example, a small floor space installation system can occupy about 1 m ² or less of floor space. In some embodiments, the instrument footprint may be less than or equal to about 4m ² , 3m ² , 2.5m ² , 2m ² , 1.5m ² , 1m ² , 0.75m ² , 0.5m ² , 0.3m ² , 0.2 ^{m 2, 0.1m 2, 0.08m 2} , 0.05 m 2, 0.03m 2, 100cm 2, 80cm 2, 70cm 2, 60cm 2, 50cm 2, 40cm 2, 30cm 2, 20cm 2, 15cm 2 , or 10cm ^2. Some suitable systems in a point of service environment are described in US Patent Application Nos. 13 / 355,458 and 13 / 244,947, both of which are incorporated by reference for all purposes. This embodiment can be configured for use with any module or system described in the cited patent application.

現請參考圖33至37，現將說明樣本採集裝置又一實施例。如圖33及34所示，至少一個實施例顯示具有毛細通道區域之樣本採集區域2600，以及提高通道剖面面積以獲得較低流動阻力及更高流量之較低流動阻力區域2610。於至少一個實施例中，此較低流動阻力區域2610依然為毛細通道，惟具有較低流動阻力。可選地，其他實施例可增加樣本於其中不因毛細作用而流動之尺寸。通道之該增加尺寸亦可被用於存儲樣本。作為非限制性實例，此儲存可為採集過程中臨時所為、較長期，諸如用於自採集地點運送至冷藏、自採集地點運送至接收地點、其他地點至地點運送，或其他用途。一個實施例可被配置為於裝置兩端均設有蓋，使得樣本被容納於其內，毋需傳遞至容器1146a及1146b。 Referring now to FIGS. 33 to 37, another embodiment of the sample collection device will now be described. As shown in FIGS. 33 and 34, at least one embodiment shows a sample collection area 2600 having a capillary channel area, and a lower flow resistance area 2610 that increases the channel cross-sectional area to obtain lower flow resistance and higher flow. In at least one embodiment, the lower flow resistance region 2610 is still a capillary channel, but has lower flow resistance. Optionally, other embodiments may increase the size in which the sample does not flow due to capillary action. This increased size of the channel can also be used to store samples. As a non-limiting example, this storage may be temporary during the collection process, for a longer period of time, such as for transportation from the collection location to refrigeration, transportation from the collection location to the receiving location, other location to location transportation, or other uses. One embodiment can be configured with lids on both ends of the device so that the sample is contained within it without transferring to the containers 1146a and 1146b.

因為區域2600及2610間連接可被置於穿越中心線2620，故用於連接所述部件之連接材料量可得以減少。應暸解，實施例中，通道2612及2614可具有相同剖面尺寸和/或被配置為於通道中容納相同或相當大程度地相同之體積。可選地，通道2612及2614可被配置為容納 不同體積。當通道繼續進入區域2610時，這一點亦可適用。可選地，一些實施例於區域2610中可具有不同尺寸，同時於區域2600中具有相同尺寸，或反之。並未排除其他尺寸配置。儘管通道於此處顯示為線性，應暸解，對於本文所揭示任意實施例，一些實施例可具有彎曲或其他非筆直通道部分。 Because the connection between the regions 2600 and 2610 can be placed across the centerline 2620, the amount of connection material used to connect the components can be reduced. It should be appreciated that in embodiments, the channels 2612 and 2614 may have the same cross-sectional dimensions and / or be configured to accommodate the same or substantially the same volume in the channels. Optionally, channels 2612 and 2614 can be configured to accommodate Different volumes. This also applies when the channel continues to enter area 2610. Alternatively, some embodiments may have different sizes in the area 2610, while having the same size in the area 2600, or vice versa. Other size configurations are not excluded. Although the channels are shown here as linear, it should be understood that for any of the embodiments disclosed herein, some embodiments may have curved or other non-straight channel portions.

就容器containers 1146a及1146b、轉接通道、熔塊、支座130等而言，其他部分與本文前述類似。兩條通道於連接處之吸收性(兩者填充時間皆<6秒)業已經改良(去除步驟)，且血液可方便地進入通道，並毋需傾斜即可通過連接區域。所述部件可由PMMA、PET、PETG等製成。蓋因區域2610中通道尺寸之變化，使得流入此區域更容易，由此填滿可得以加快7.5x。 As far as the containers 1146a and 1146b, the transition channel, the frit, the support 130, etc. are concerned, the other parts are similar to those mentioned above. The absorption of the two channels at the connection (both filling time <6 seconds) has been improved (removal step), and blood can easily enter the channel and can pass through the connection area without tilting. The components can be made of PMMA, PET, PETG, etc. The change in the size of the channel in the area 2610 makes it easier to flow into this area, so filling can be accelerated by 7.5x.

依照通道尺寸之變化，區域2610中流動阻力降至四次方，如以下公式所示。 According to the change of the channel size, the flow resistance in the area 2610 drops to the fourth power, as shown in the following formula.

應暸解，當通道中存在有所需量之樣本，一些實施例可被配置為，樣本可經操作被移至儲存容器中。作為非限制性實例，此樣本移動可籍由拉力、推力或兩者皆可完成。於一個實施例中，拉力可由其中為真空之容器、具有透過移動增大體積並抽吸樣本之活塞或其他可移動表面的容器，或主動真空力提供。於一個實施例中，推力可 為圓物塊或其他液體團後側所提供空氣或其他氣體產生之壓力。於實施例中，可施加壓縮氣體、與裝置間形成密封之蓋於採集裝置上滑過產生之壓力、與一端耦合並施加氣體壓力之注射器，或其他力以推動氣體朝前。所提供之力可不同於採集通道中樣本所用之動力。可選地，一些實施例可為各通道使用不同動力。可選地，一些實施例可相對於區域2610，於區域2600中採用不同動力。 It should be understood that when there is a required amount of sample in the channel, some embodiments may be configured such that the sample can be moved to the storage container by operation. As a non-limiting example, this sample movement can be done by pulling force, pushing force, or both. In one embodiment, the pulling force may be provided by a container in which there is a vacuum, a container with a piston or other movable surface that increases the volume through movement and draws the sample, or an active vacuum force. In one embodiment, the thrust can be The pressure generated by the air or other gas provided on the back side of a round block or other liquid mass. In an embodiment, a compressed gas may be applied, a lid forming a seal with the device slides on the collecting device to generate pressure, a syringe coupled to one end and applying gas pressure, or other force to push the gas forward. The force provided may be different from the power used to collect the sample in the channel. Alternatively, some embodiments may use different power for each channel. Alternatively, some embodiments may employ different power in the area 2600 relative to the area 2610.

有關教導雖是經參照特定實施例得以說明並繪示，本發明所屬技術領域中具有通常知識者應暸解，可對程序及規程作出各種修改、變化、改變、替換、刪除或添加，而不背離本發明之精神及範疇。舉例而言，對於上述任意實施例，應暸解，液體樣本可為全血、稀釋血、細胞間液、直接採自病患之樣本】位於表面之樣本、經過某些前處理之樣本等等。本發明所屬技術領域中具有通常知識者應暸解，替代實施例可具有超過一個容器，其可依序可***作地與針頭或通道開口耦合，以抽取液體進入容器。可選地，一些實施例可具有配置為同時可***作地與通道耦合之容器。一些實施例可將切口裝置或其他傷口產生裝置與樣本採集裝置整合，將目標樣本液體取至組織表面，隨後採集該等樣本液體，全部過程皆運用單件裝置。作為非限制性實例，彈簧致動、機械致動和/或電動機械致動組織穿刺部件之安裝形式使其穿刺尖端於鄰近接近樣本採集通道開口之樣本採集裝置末端處退出，由此亦將沿與採集開口相同之裝置末端產生傷口。可選地，一體化裝置可 於某一表面設有採集開口，而沿裝置另一表面設有組織穿刺元件。於本文所揭示任意實施例中，採集通道第一開口可具有鈍形，其被配置為不輕易地刺破人類皮膚。 Although the relevant teachings have been described and illustrated with reference to specific embodiments, those with ordinary knowledge in the technical field to which the present invention belongs should understand that various modifications, changes, changes, replacements, deletions, or additions to procedures and procedures can be made without departing The spirit and scope of the present invention. For example, for any of the above embodiments, it should be understood that the liquid sample may be whole blood, diluted blood, intercellular fluid, or a sample taken directly from the patient] a sample located on the surface, a sample subjected to some pretreatment, and so on. Those of ordinary skill in the art to which this invention pertains should understand that alternative embodiments may have more than one container, which may be sequentially operably coupled with a needle or channel opening to draw liquid into the container. Alternatively, some embodiments may have a container configured to be operably coupled to the channel at the same time. Some embodiments may integrate an incision device or other wound-generating device with a sample collection device, take the target sample liquid to the tissue surface, and then collect the sample liquid, all processes using a single piece device. As a non-limiting example, the spring-actuated, mechanically-actuated, and / or electro-mechanically-actuated tissue-piercing component is installed in such a way that the puncture tip exits adjacent to the end of the sample collection device near the opening of the sample collection channel, which will also follow A wound is created at the end of the same device as the collection opening. Alternatively, the integrated device may A collection opening is provided on one surface, and a tissue-piercing element is provided along the other surface of the device. In any of the embodiments disclosed herein, the first opening of the collection channel may have a blunt shape, which is configured not to easily pierce human skin.

另外，於手指或其他目標組織上運用發熱貼，可加大流至目標區域的血流，由此提高從對象抽取充足血液或其他體液之速度。所述加熱被用於將目標組織升溫至約40C至50C。可選地，所述加熱將目標組織升溫至約44至47C。 In addition, applying a heat patch on the finger or other target tissue can increase the blood flow to the target area, thereby increasing the speed of drawing sufficient blood or other body fluids from the subject. The heating is used to warm the target tissue to about 40C to 50C. Optionally, the heating raises the target tissue to about 44 to 47C.

此外，本發明所屬技術領域中具有通常知識者應暸解，本文所述任意實施例可被運用於自人類、動物或其他對象採集樣本液體。本文所述一些實施例亦可適用於採集非生物液體樣本。一些實施例可使用不可從載體上移除的容器。一些實施例可於液體樣本在樣本採集部分經過計量後，籍由第二動力引導所述液體樣本至匣之，其隨後被放入分析物或其他分析裝置。可選地，應瞭解，儘管很多實施例顯示容器位於載體中，並未排除裸露容器或未安裝於載體中的容器之實施例。一些實施例可具有與裝置分開之容器，其僅當通道達到最低填充程度時方形成液體連通。舉例而言，容器可被保持於一個不同位置，僅當樣本採集裝置中具有足量血液或樣本液體時，方由技師將其帶至接觸位置。於其時，容器可同時或依序與樣本採集裝置之一條或多條通道形成液體連通。 In addition, those of ordinary skill in the technical field to which the present invention pertains should understand that any of the embodiments described herein can be applied to collect sample liquids from humans, animals, or other subjects. Some embodiments described herein are also applicable to collecting non-biological liquid samples. Some embodiments may use containers that are not removable from the carrier. In some embodiments, after the liquid sample is measured in the sample collection part, the liquid sample is guided to the cartridge by the second power, which is then placed into the analyte or other analysis device. Alternatively, it should be understood that although many embodiments show that the container is located in the carrier, embodiments that do not exclude bare containers or containers that are not installed in the carrier are not excluded. Some embodiments may have a container separate from the device that only forms liquid communication when the channel reaches a minimum filling level. For example, the container can be held in a different position, and only when there is a sufficient amount of blood or sample liquid in the sample collection device, can the technician take it to the contact position. At that time, the container may be in liquid communication with one or more channels of the sample collection device simultaneously or sequentially.

另外，濃度、量及其他數值資料可以範圍形式出現於本文中。應瞭解，此類範圍僅為方便、簡明起見而 採用，其應靈活解釋，以不僅包括明確揭示之數值限定的範圍，還應包括所述範圍中全部單個數值或其所包含之子範圍，如同各數值及子範圍被明確揭示。舉例而言，從約1nm至約200nm之尺寸範圍應被理解為不僅包括明確揭示之從約1nm至約200nm的數值限定，還應包括其中單個尺寸，如2nm、3nm、4nm，及子範圍，如10nm至50nm、20nm至100nm等等。 In addition, the concentration, amount and other numerical data can appear in the form of a range. It should be understood that such ranges are for convenience and conciseness only When used, it should be flexibly interpreted to include not only the explicitly defined numerical range but also all individual numerical values in the stated range or sub-ranges contained therein, as if the numerical values and sub-ranges were clearly disclosed. For example, the size range from about 1 nm to about 200 nm should be understood to include not only the explicitly disclosed numerical limits from about 1 nm to about 200 nm, but also include individual sizes, such as 2 nm, 3 nm, 4 nm, and sub-ranges, Such as 10nm to 50nm, 20nm to 100nm and so on.

運送容器Shipping container

現請參考圖38A-38B，其繪示依據本文所述一個實施例所提供運送容器3200之非限制性實例的分解透視圖。應瞭解，運送容器3200可被配置為具有本文他處所述任意其他容器之一項或多項特徵。作為非限制性實例，運送容器3200可用於運送其中一個或多個樣本器皿。於一些實施例中，運送容器3200提供熱控制內部區域，將運送至諸如但不限於分析設施等另一位置過程中的不利樣本分解降至最低。應瞭解，可於運送過程中將運送容器置於一個或多個其他容器中。 Reference is now made to FIGS. 38A-38B, which show exploded perspective views of non-limiting examples of shipping containers 3200 provided in accordance with one embodiment described herein. It should be appreciated that the shipping container 3200 may be configured to have one or more features of any other container described elsewhere herein. As a non-limiting example, the shipping container 3200 can be used to transport one or more of the sample vessels. In some embodiments, the shipping container 3200 provides a thermally controlled internal area, minimizing adverse sample decomposition during shipping to another location such as, but not limited to, an analysis facility. It should be understood that the shipping container may be placed in one or more other containers during shipping.

於一個實施例中，可提供採集有體液樣本之樣本採集裝置的樣本器皿。作為非限制性實例，所述樣本器皿中可包含液體形態之樣本。於多數實施例中，液體形態亦包括混懸液實施例。 In one embodiment, a sample vessel of a sample collection device where a body fluid sample is collected can be provided. As a non-limiting example, the sample vessel may contain a sample in liquid form. In most embodiments, the liquid form also includes suspension embodiments.

作為非限制性實例，運送容器3200可具有任意尺寸。於一些實例中，運送容器3200可具有之總體積小於或等於約1m³、0.5m³、0.1m³、0.05m³、0.01m³、 1000cm³、500cm³、300cm³、200cm³、150cm³、100cm³、70cm³、50cm³、30cm³、20cm³、15cm³、10cm³、7cm³、5cm³、3cm³、2cm³、1.5cm³、1cm³、700mm³、500mm³、300mm³、100mm³、50mm³、30mm³、10mm³、5mm³或1mm³。運送容器之佔地面積和/或最大剖面面積可為小於或等於約1m²、0.5m²、0.1m²、0.05m²、100cm²、70cm²、50cm²、30cm²、20cm²、15cm²、10cm²、7cm²、5cm²、3cm²、2cm²、1.5cm²、1cm²、70mm²、50mm²、30mm²、10mm²、5mm²或1mm²。於一些實例中，運送容器可具有之尺寸(例如高度、寬度、長度、對角或圓周)為小於或等於約1m、75cm、50cm、30cm、25cm、20cm、15cm、12cm、10cm、9cm、8cm、7cm、6cm、5cm、4cm、3cm、2cm、1cm、0.7cm、0.5cm、0.3cm或1mm。於一些實例中，運送容器之最大尺寸可不大於約1m、75cm、50cm、30cm、25cm、20cm、15cm、12cm、10cm、9cm、8cm、7cm、6cm、5cm、4cm、3cm、2cm、1cm、0.7cm、0.5cm、0.3cm或1mm。 As a non-limiting example, the shipping container 3200 may have any size. The total volume in some examples, may have a transport container 3200 is less than or equal to about ^{1m 3, 0.5m 3, 0.1m 3} , 0.05m 3, 0.01m 3, 1000cm 3, 500cm 3, 300cm 3, 200cm 3, 150cm 3 , 100cm ³ , 70cm ³ , 50cm ³ , 30cm ³ , 20cm ³ , 15cm ³ , 10cm ³ , 7cm ³ , 5cm ³ , 3cm ³ , 2cm ³ , 1.5cm ³ , 1cm ³ , 700mm ³ , 500mm ³ , 300mm ³ , 100mm ³ , 50mm ³ , 30mm ³ , 10mm ³ , 5mm ³ or 1mm ³ . The footprint and / or maximum cross-sectional area of the shipping container may be less than or equal to about 1m ² , 0.5m ² , 0.1m ² , 0.05m ² , 100cm ² , 70cm ² , 50cm ² , 30cm ² , 20cm ² , 15cm ² , 10cm ² , 7cm ² , 5cm ² , 3cm ² , 2cm ² , 1.5cm ² , 1cm ² , 70mm ² , 50mm ² , 30mm ² , 10mm ² , 5mm ² or 1mm ² . In some examples, the shipping container may have dimensions (eg, height, width, length, diagonal, or circumference) less than or equal to about 1 m, 75 cm, 50 cm, 30 cm, 25 cm, 20 cm, 15 cm, 12 cm, 10 cm, 9 cm, 8 cm , 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm, 0.7cm, 0.5cm, 0.3cm or 1mm. In some examples, the maximum size of the shipping container may not be greater than about 1m, 75cm, 50cm, 30cm, 25cm, 20cm, 15cm, 12cm, 10cm, 9cm, 8cm, 7cm, 6cm, 5cm, 4cm, 3cm, 2cm, 1cm, 0.7 cm, 0.5cm, 0.3cm or 1mm.

可選地，運送容器可為輕型。於一些實施例中，運送容器重量可輕於或等於約10kg、5kg、4kg、3kg、2kg、1.5kg、1kg、0.7kg、0.5kg、0.3kg、100g、70g、50g、30g、20g、15g、10g、7g、5g、3g、2g、1g、500mg、300mg、200mg、100mg、70 mg、50mg、30mg、10mg、5mg或1mg，其可帶或不帶其中具有樣本之樣本器皿。 Alternatively, the shipping container may be lightweight. In some embodiments, the weight of the shipping container may be less than or equal to about 10kg, 5kg, 4kg, 3kg, 2kg, 1.5kg, 1kg, 0.7kg, 0.5kg, 0.3kg, 100g, 70g, 50g, 30g, 20g, 15g , 10g, 7g, 5g, 3g, 2g, 1g, 500mg, 300mg, 200mg, 100mg, 70 mg, 50mg, 30mg, 10mg, 5mg, or 1mg, which may or may not contain a sample vessel with a sample in it.

如圖38A及38B所示，運送容器之一個實施例可具有頂蓋3210、用於熱調節裝置3220之外殼、用於運送容器3230a,3230b之一個或多個插盤，及底板3240。 As shown in FIGS. 38A and 38B, one embodiment of the shipping container may have a top cover 3210, a housing for the thermal adjustment device 3220, one or more inserts for shipping containers 3230a, 3230b, and a bottom plate 3240.

於一個實施例中，頂蓋3210具有相當程度平坦地形狀，惟並未排除其他形狀。頂蓋3210可覆蓋熱調節裝置，諸如但不限於容置於運送容器中的加熱器或冷卻器。頂蓋可能或可能不具有與用於熱調節裝置3220之外殼相同的佔地面積。可於運送容器3200中設置冷卻器、加熱器或其他熱調節裝置3220。可選地，裝置3220可為主動或被動單元。熱調節裝置可將運送容器3200中的樣本器皿保持於所需溫度或低於預定溫度門檻值。可選地，熱調節裝置可為本發明所屬技術領域中任意習知溫度控制單元。可選地，熱調節裝置能夠加熱和/或冷卻。可選地，熱調節裝置可為熱電冷卻器。可選地，熱調節裝置可被包裹於頂蓋及冷卻器外殼之間。 In one embodiment, the top cover 3210 has a relatively flat shape, but other shapes are not excluded. The top cover 3210 may cover a heat regulating device, such as but not limited to a heater or cooler housed in a shipping container. The top cover may or may not have the same footprint as the housing for the thermal adjustment device 3220. A cooler, heater, or other thermal adjustment device 3220 may be provided in the shipping container 3200. Alternatively, the device 3220 may be an active or passive unit. The thermal adjustment device may maintain the sample vessel in the transport container 3200 at a desired temperature or below a predetermined temperature threshold. Alternatively, the thermal adjustment device may be any conventional temperature control unit in the technical field to which the present invention belongs. Alternatively, the thermal conditioning device can heat and / or cool. Alternatively, the thermal regulation device may be a thermoelectric cooler. Alternatively, the thermal adjustment device may be wrapped between the top cover and the cooler housing.

可選地，頂蓋及外殼可能或可能不構成氣密密封。頂蓋和/或外殼可由具有所需熱傳導率之材料製成。例如外殼3220可具有可選擇熱傳導率。於一個實施例中，外殼可於盒材料中包括嵌入式相變材料(PCM)，如此，溫度於各處均為相當大程度地一致。PCM具有極佳溫度特徵。宜於不過度冷卻樣本，比如與冰相關之冷卻，其可產生負下降至-5ºC。PCM可被配置為控制溫度範圍高於冷 凍。作為非限制性實例，熱傳導率可處於約100-250W/m/K(瓦特/米/開氏溫標)之範圍內。可選地，各樣本器皿將與PCM接觸。一些實施例可為各層提供一個PCM。所述PCM材料可經流動模製進入容器材料。可選地，托盤中空隙可由PCM填滿。PCM可提供被動熱控制技術。 Optionally, the top cover and the housing may or may not form an airtight seal. The top cover and / or housing may be made of a material with a desired thermal conductivity. For example, the housing 3220 may have a selectable thermal conductivity. In one embodiment, the housing may include embedded phase change material (PCM) in the box material, so that the temperature is fairly uniform everywhere. PCM has excellent temperature characteristics. It is advisable not to over-cool the sample, such as ice-related cooling, which can produce a negative drop to -5ºC. PCM can be configured to control the temperature range above the cold freeze. As a non-limiting example, the thermal conductivity may be in the range of about 100-250 W / m / K (watts / meters / Kelvin scale). Optionally, each sample vessel will be in contact with the PCM. Some embodiments may provide one PCM for each layer. The PCM material can be flow molded into the container material. Alternatively, the gap in the tray can be filled by PCM. PCM can provide passive thermal control technology.

可選地，PCM可被包含於注塑成型材料中。於如此一個實施例中，整個容器可成為冷卻媒介。這亦可防止PCM從容器室中洩漏。當PCM被直接包含於容器材料中時，還可縮減容器尺寸。能量密度更高，蓋因單位質量之儲存能力得以提升。將塑料與PCM材料混合，可被配置為兼具強度及冷卻。作為非限制性實例，30%的材料可為PCM，餘者為塑料以獲得剛性。作為非限制性實例，20%至40%的材料可為PCM，餘者為諸如但不限於塑料等的另一種材料以獲得機械剛性。一些實施例可採用充滿PCM或其他材料之吹塑成型外層。內層係可籍由不同技術成型，因內層是否美觀並不重要。可選地，亦可運用鑄塑或其他低溫成型工藝取代或聯合PCM整合容器材料之注塑成型。嵌入式PCM亦可處於托盤中。一些實施例之托盤可為更具熱傳導性，以實現均勻一致的冷卻特徵。可選地，PCM材料被包含於位於運送容器底盤中的室中，其中室壁可比運輸盒底盤其他區域的壁厚薄。 Alternatively, PCM may be included in the injection molding material. In such an embodiment, the entire container can be the cooling medium. This also prevents PCM from leaking from the container room. When the PCM is directly contained in the container material, the container size can also be reduced. The higher the energy density, the higher the storage capacity of the unit of mass. Mixing plastic with PCM material can be configured to have both strength and cooling. As a non-limiting example, 30% of the material may be PCM, and the rest is plastic for rigidity. As a non-limiting example, 20% to 40% of the material may be PCM, and the remainder is another material such as but not limited to plastic to obtain mechanical rigidity. Some embodiments may use a blow molded outer layer filled with PCM or other materials. The inner layer can be formed by different techniques, because whether the inner layer is beautiful or not is not important. Alternatively, it can also use injection molding or other low-temperature molding processes to replace or integrate injection molding of PCM integrated container materials. The embedded PCM can also be in the tray. The trays of some embodiments may be more thermally conductive to achieve uniform cooling characteristics. Optionally, the PCM material is contained in a chamber in the chassis of the shipping container, where the walls of the chamber may be thinner than those of other areas of the chassis of the shipping box.

於一個實施例中，運送容器3200亦可使托盤3230a及3230b各自配置為：樣本器皿上的任意資訊儲存 單元可方便地讀取，而不需將樣本器皿從托盤3230a及3230b上移除。於一個實例中，支座於底部設有開口，其使得當樣本器皿保持在托盤3230a及3230b中時，可看到底部資訊儲存單元。 In one embodiment, the shipping container 3200 may also configure the trays 3230a and 3230b to: store any information on the sample vessel The unit can be easily read without removing the sample vessels from the trays 3230a and 3230b. In one example, the support is provided with an opening at the bottom, which allows the bottom information storage unit to be seen when the sample vessel is held in the trays 3230a and 3230b.

圖39繪示運送容器3200的多個視圖。一些視圖顯示，托盤3230a或3230b中的樣本器皿支座可具有開放式底部，使得諸如但限於條碼或其他資訊儲存單元的任意資訊儲存單元可從下方或不需要將樣本器皿從運送容器3200上移除的其他方向加以讀取。可選地，運送容器3200僅有特定部分，諸如但不限於某一層、某一托盤或類似物，被移除以獲取所需資訊。可選地，可透過托盤中一個或多個開口訪問條碼或其他資訊儲存單元。由此可對極小運送容器進行條碼掃描。可選地，可單獨掃描各樣本行或可同時掃描整個托盤。可選地，使用者可看到所有樣本器皿支座。可選地，電腦視覺系統亦可進行掃描，以觀察如離心分離等步驟是否完成。這可於運輸過程兩頭進行皆可。所述電腦視覺系統可觀察樣本器皿，並判定其中樣本是否處於某種形態，由此確認所需步驟已經完成。如其檢測到錯誤，該系統可通知使用者或系統有關問題和/或重新執行缺失和/或錯誤執行之步驟。可選地，支座可具有封閉式底部，資訊可位於運送容器3200側面或其他表面。 FIG. 39 illustrates multiple views of the shipping container 3200. Some views show that the sample vessel holder in the tray 3230a or 3230b can have an open bottom so that any information storage unit such as but not limited to a barcode or other information storage unit can move the sample vessel from the shipping container 3200 from below or without Read in other directions. Optionally, only certain parts of the shipping container 3200, such as but not limited to a certain layer, a certain tray or the like, are removed to obtain the required information. Optionally, barcodes or other information storage units can be accessed through one or more openings in the tray. This allows barcode scanning of extremely small shipping containers. Alternatively, each sample row can be scanned individually or the entire tray can be scanned simultaneously. Optionally, the user can see all sample vessel supports. Optionally, the computer vision system can also scan to see if steps such as centrifugal separation are completed. This can be done at both ends of the transportation process. The computer vision system can observe the sample vessel and determine whether the sample is in a certain form, thereby confirming that the required steps have been completed. If it detects an error, the system may notify the user or the system about the problem and / or re-execute the missing and / or incorrectly executed steps. Optionally, the stand may have a closed bottom, and the information may be located on the side or other surface of the shipping container 3200.

於一些實施例中，支座形狀亦可設計為於其中樣本器皿3134輪廓相配，以提高表面面積接觸，並改良樣本器皿之熱控制。可選地，樣本器皿之熱控制可經由與托 盤和/或PCM的熱傳遞實現，惟其不與PCM直接接觸。可選地，一些樣本器皿3134亦可與容器和/或PCM直接接觸。樣本器皿和/或支座之開口可為直線行、蜂窩型或其他型式佈置。 In some embodiments, the shape of the support can also be designed to match the contour of the sample vessel 3134 to increase surface area contact and improve thermal control of the sample vessel. Alternatively, the thermal control of the sample vessel can be The heat transfer of the disk and / or PCM is achieved, but it is not in direct contact with the PCM. Optionally, some sample vessels 3134 may also be in direct contact with the container and / or PCM. The openings of the sample vessels and / or supports can be arranged in a straight line, honeycomb type or other types.

現請參考圖40A及40B，其繪示完整組合後的運送容器3200。圖40B繪示複數個樣本器皿3134，即與樣本採集裝置相關之樣本器皿。樣本器皿3134可全部用於某一對象之樣本，於此情形中，可使用與托盤3230a相關的資訊儲存單元提供此組樣本的資訊。可選地，單個樣本器皿可各自具有一個資訊儲存單元，其與托盤3230a的資訊儲存單元相同，或其可為各自不同。一些實施例可將採自多個對象的樣本器皿***同一托盤3230a。可選地，一些實施例可僅部分填充各托盤。一些實施例可填滿托盤中各開口，惟並不是各樣本器皿均包含樣本(即，一些空樣本器皿可被***以提供均勻熱特徵)。這些可堆疊托盤3230a可具有封閉裝置，其採用諸如但不限於磁鐵、機械搭扣或其他耦合機制等元件將托盤耦合在一起。於一些實施例中，可運用磁鐵接合容置有樣本器皿之托盤，由此便於自動裝卸過程中的打開。可選地，使用者不可將托盤從容器上移除。可選地，如使用者不使用工具釋放托盤，則無法將托盤從容器上移除。一些實施例具有鍵控機制(磁性或其他技術)。於此種方式中，病患服務中心可將樣本放入，卻無法將其取出。可選地，一些實施例可設有特選成型開口，使得無法以錯誤方式放置樣本器皿和/或其支 座，由此避免使用者錯誤。 Now please refer to FIGS. 40A and 40B, which illustrate the transport container 3200 after being completely assembled. FIG. 40B illustrates a plurality of sample vessels 3134, that is, sample vessels related to the sample collection device. The sample vessel 3134 can be used for all samples of a certain object. In this case, the information storage unit related to the tray 3230a can be used to provide information of this group of samples. Alternatively, the individual sample vessels may each have an information storage unit, which is the same as the information storage unit of the tray 3230a, or it may be different from each other. Some embodiments may insert sample vessels collected from multiple subjects into the same tray 3230a. Alternatively, some embodiments may only partially fill each tray. Some embodiments may fill the openings in the tray, but not every sample vessel contains a sample (ie, some empty sample vessels may be inserted to provide uniform thermal characteristics). These stackable trays 3230a may have a closure device that uses elements such as but not limited to magnets, mechanical snaps, or other coupling mechanisms to couple the trays together. In some embodiments, magnets may be used to engage the tray containing the sample vessels, thereby facilitating opening during automatic loading and unloading. Alternatively, the user cannot remove the tray from the container. Alternatively, if the user does not use the tool to release the tray, the tray cannot be removed from the container. Some embodiments have a keying mechanism (magnetic or other technology). In this way, the patient service center can put the sample in, but cannot take it out. Optionally, some embodiments may be provided with specially shaped openings so that the sample vessel and / or its support cannot be placed in the wrong way Seat, thereby avoiding user error.

於一個實施例中，載入和/或卸除可於溫度調控室或腔中進行，從而將樣本維持於所需溫度範圍內。於一個實施例中，溫度範圍宜為約1º至10ºC。可選地，溫度範圍宜為約2º至8ºC。溫度範圍宜為約4º至5ºC。可選地，托盤230a及230b材料可用於為樣本器皿提供熱控制氣氛。一些實施例採用對流控制運送容器200中的熱特徵。 In one embodiment, loading and / or unloading can be performed in a temperature-controlled chamber or chamber to maintain the sample within the desired temperature range. In one embodiment, the temperature range is preferably about 1º to 10ºC. Optionally, the temperature range is preferably about 2º to 8ºC. The temperature range should be approximately 4º to 5ºC. Alternatively, the tray 230a and 230b materials can be used to provide a thermally controlled atmosphere for the sample vessel. Some embodiments employ convection to control the thermal characteristics in the shipping container 200.

圖40B亦繪示，於此特定實施例中，係可設有槽3232，用於可提供運送容器各層間緊密連接的O型環或其他密封。系統亦可包括封閉機制3234，諸如但不限於磁性封閉機制，使可堆疊插盤保持於所需位置。還應暸解，一些實施例可具有通孔3236，用於為傳感器配線，以檢測可堆疊插盤於運輸中所經歷條件。 FIG. 40B also shows that in this particular embodiment, a groove 3232 can be provided for providing an O-ring or other seal that is tightly connected between the layers of the shipping container. The system may also include a closure mechanism 3234, such as, but not limited to, a magnetic closure mechanism to keep the stackable tray in the desired position. It should also be appreciated that some embodiments may have through holes 3236 for wiring the sensors to detect the conditions experienced by the stackable insert during transportation.

圖40C繪示，當諸如可堆疊插盤及蓋等各部件連接形成運送容器3200時，圖40A及40B中實施例的各種透視圖。如圖40C所示，運送容器可由多層樣本器皿組成。可選地，一些實施例可僅具有單層樣本器皿。一些實施例可於運送容器3200之一層或多層中採用主動冷卻或熱控制。作為非限制性實例，一個實施例可於頂層設有熱-電冷卻器。可選地，一些實施例可採用主動和被動熱控制組合。作為非限制性實例，一個實施例可設有諸如但不限於相變材料(PCM)等的熱材料，其已處於所需溫度。係可包括主動熱控制單元，使PCM保持於所需溫度範圍內。 可選地，一些實施例可僅使用諸如但不限於PCM等一種熱材料，將溫度保持於所需範圍內。 FIG. 40C illustrates various perspective views of the embodiments in FIGS. 40A and 40B when various components such as stackable inserts and covers are connected to form the shipping container 3200. As shown in FIG. 40C, the shipping container may be composed of multi-layer sample vessels. Alternatively, some embodiments may have only a single layer of sample vessels. Some embodiments may employ active cooling or thermal control in one or more layers of the shipping container 3200. As a non-limiting example, one embodiment may be provided with a thermo-electric cooler on the top layer. Alternatively, some embodiments may employ a combination of active and passive thermal control. As a non-limiting example, one embodiment may be provided with a thermal material such as, but not limited to, phase change material (PCM), which is already at the desired temperature. The system may include an active thermal control unit to keep the PCM within the desired temperature range. Alternatively, some embodiments may use only one thermal material such as but not limited to PCM to maintain the temperature within the desired range.

具有可移除托盤之運送容器Transport container with removable tray

現請參考圖41，現將說明運送容器又一實施例。圖41繪示運送容器3300，其具有熱控制內部3302，其容納可以陣列架構容置複數個樣本器皿3306的托盤3304，其中各樣本器皿3306以自由流動、非吸收形態容納其大多數樣本，且其中各器皿中有約1ml或更少之樣本液體。可選地，各器皿中有約2ml或更少之樣本液體。可選地，各器皿中有約3ml或更少之樣本液體。於一個非限制性實例中，器皿放置形式使得各運送容器具有至少兩個器皿裝有採自同一對象之體液樣本，其中至少第一樣本於基質中包括第一抗凝劑，第二樣本於基質中包括第二抗凝劑。 Referring now to FIG. 41, another embodiment of the shipping container will now be described. FIG. 41 illustrates a shipping container 3300 with a thermally controlled interior 3302 that houses a tray 3304 that can accommodate a plurality of sample vessels 3306 in an array architecture, where each sample vessel 3306 contains most of its samples in a free-flowing, non-absorbent form, and There is about 1ml or less of sample liquid in each vessel. Optionally, there are about 2 ml or less of sample liquid in each vessel. Optionally, there are about 3 ml or less of sample liquid in each vessel. In a non-limiting example, the vessel is placed in a form such that each shipping container has at least two vessels containing body fluid samples taken from the same subject, wherein at least the first sample includes a first anticoagulant in the matrix and the second The matrix includes a second anticoagulant.

儘管圖41繪示樣本器皿3306以陣列架構放置，並未排除其他預定配置型式。一些實施例可將樣本器皿置於托盤中的鉸接式、擺動式或其他保持機制中，使其具有一個或兩個自由度之移動。一些實施例可將樣本器皿置於某一裝置中，該裝置於載入時具有第一配置，隨後於運送過程中以第二配置保持樣本器皿。一些實施例可將樣本器皿置於某一材料中，該材料於載入時具有第一材料特性，隨後於運送過程中以諸如但不限於硬化等第二特性保持樣本器皿。 Although FIG. 41 shows that the sample vessel 3306 is placed in an array structure, other predetermined configuration types are not excluded. Some embodiments may place the sample vessel in a hinged, swinging, or other holding mechanism in the tray, giving it one or two degrees of freedom of movement. Some embodiments may place the sample vessel in a device that has a first configuration when loaded, and then holds the sample vessel in a second configuration during shipping. Some embodiments may place the sample vessel in a material that has a first material characteristic when loaded, and then holds the sample vessel with a second characteristic such as but not limited to hardening during shipping.

於一些實施例中，樣本器皿處於支座3310中， 托盤3304限定開口和/或空腔，其尺寸適合支座3310，而不適合樣本器皿。作為非限制性實例，支座3310可被用於將相關器皿3306於托盤3304中處於同一物理位置。一些實施例中，支座3310直接接觸托盤3304，使得器皿得以受到保護，不與托盤3304接觸。於一個非限制性實例中，托盤可容納至少100個器皿，或可選地，至少50個各自具有兩個器皿的支座。 In some embodiments, the sample vessel is in the holder 3310, The tray 3304 defines an opening and / or cavity and is sized for the holder 3310, but not for the sample vessel. As a non-limiting example, the stand 3310 may be used to place the related vessels 3306 in the same physical location in the tray 3304. In some embodiments, the holder 3310 directly contacts the tray 3304, so that the vessel is protected from contact with the tray 3304. In one non-limiting example, the tray can accommodate at least 100 vessels, or alternatively, at least 50 supports each having two vessels.

仍請參考圖41，運送容器3300的此實施例可具有一些保持機制3320，諸如但不限於夾子、磁性區域或類似物以容納托盤3306。所述保持機制3320可被配置為以根據需要可加以釋放之方式容納托盤3304。可選地，所述保持機制3320可被配置為以不可釋放之方式容納托盤3304。於圖41所示實施例中，繪示所述保持機制3320為托盤3304中的磁性和/或金屬部件，其被吸引至容器3300中的金屬和/或磁性部件。當運送容器3300抵達處理設施時，托盤3304可被配置為從容器3300中移除。這可籍由一種或多種技術完成，包括但不限於使用強磁鐵接合托盤3304中的磁性和/或金屬部件。一些實施例可使用夾鉗、鉤子或其他機械機制，將托盤3304從容器3300中移除。一些實施例可使用技術組合移除托盤3304。還應暸解，一些實施例可選擇移除器皿3306和/或支座3310，而托盤3304則保留於容器3300中。一些技術可採用一種或多種前述技術。 Still referring to FIG. 41, this embodiment of the shipping container 3300 may have some retention mechanisms 3320, such as but not limited to clips, magnetic areas, or the like to accommodate the tray 3306. The retention mechanism 3320 can be configured to receive the tray 3304 in a manner that can be released as needed. Alternatively, the retention mechanism 3320 may be configured to receive the tray 3304 in a non-releasable manner. In the embodiment shown in FIG. 41, the holding mechanism 3320 is shown as a magnetic and / or metal component in the tray 3304, which is attracted to the metal and / or magnetic component in the container 3300. When the shipping container 3300 arrives at the processing facility, the tray 3304 may be configured to be removed from the container 3300. This can be accomplished by one or more techniques, including but not limited to the use of strong magnets to engage the magnetic and / or metal components in tray 3304. Some embodiments may use clamps, hooks, or other mechanical mechanisms to remove the tray 3304 from the container 3300. Some embodiments may use a combination of techniques to remove the tray 3304. It should also be appreciated that some embodiments may choose to remove the vessel 3306 and / or the holder 3310, while the tray 3304 remains in the container 3300. Some technologies may employ one or more of the foregoing technologies.

還應暸解，容器3300自身係可為冷卻裝置，其 包括熱控制材料，諸如但不限於冰、PCM或類似物。其他實施例可直接將熱控制材料整合於製造容器3300的材料中。如圖41所示，容器3300的一些實施例可具有相當大程度的空間3324，其中容納或整合有一種或多種熱控製材料。 It should also be understood that the container 3300 itself may be a cooling device, which Including thermal control materials such as but not limited to ice, PCM or the like. Other embodiments may directly integrate the heat control material into the material for manufacturing the container 3300. As shown in FIG. 41, some embodiments of the container 3300 may have a considerable degree of space 3324 in which one or more thermal control materials are contained or integrated.

仍請參考圖41，容器3300亦可包括開口3330以附接鉸鏈或其他連接裝置，用於蓋或與容器3300的其他層之連接。為便於繪示起見，圖41中未繪示所述蓋和/或與蓋或其他層之連接。儘管一些實施例可僅具有單層，應暸解，並未排除多層實施例。 Still referring to FIG. 41, the container 3300 may also include an opening 3330 to attach a hinge or other connecting device for a lid or connection with other layers of the container 3300. For ease of illustration, the cover and / or the connection with the cover or other layers are not shown in FIG. 41. Although some embodiments may have only a single layer, it should be understood that multilayer embodiments are not excluded.

現請參考圖42，現將說明容器3400又一實施例的分解透視圖。圖42之實施例設計用於將托盤3402容納於容器內部3404中。此分解透視圖繪示托盤3402中支座3410上的複數個器皿3406。托盤3402可被配置為具有類似於托盤3402中保持機制3320的保持機制3420之一些或所有部分。還應暸解，托盤3402可具有一個或多個使得托盤3402能夠以有限的預設方向被***內部的凹陷、凸出或特徵。一些實施例可被配置為僅允許托盤在容器中具有一個方向。一些實施例可被配置為僅允許托盤在容器中具有兩個可能方向。 Referring now to FIG. 42, an exploded perspective view of yet another embodiment of the container 3400 will now be described. The embodiment of FIG. 42 is designed to accommodate the tray 3402 in the interior 3404 of the container. This exploded perspective view shows a plurality of utensils 3406 on the support 3410 in the tray 3402. The tray 3402 may be configured to have some or all parts of a retention mechanism 3420 similar to the retention mechanism 3320 in the tray 3402. It should also be appreciated that the tray 3402 may have one or more recesses, protrusions, or features that enable the tray 3402 to be inserted into the interior in a limited preset direction. Some embodiments may be configured to only allow the tray to have one direction in the container. Some embodiments may be configured to only allow the tray to have two possible directions in the container.

圖42顯示，於一個實施例中，容器3400可由兩片分開部件3430及3432形成。可選地，一些實施例可由三片或更多片形成。可選地，一些實施例可為單片。部件3430及3432可設有***塞3434及3436填充的開口。 容器3400之內部3438可保留熱控制材料，諸如但不限於冰、PCM或類似物。其他實施例可直接將熱控制材料整合於製造容器3400的材料中。 FIG. 42 shows that, in one embodiment, the container 3400 can be formed by two separate parts 3430 and 3432. Alternatively, some embodiments may be formed from three or more pieces. Alternatively, some embodiments may be monolithic. Parts 3430 and 3432 may be provided with openings filled with plugs 3434 and 3436. The interior 3438 of the container 3400 may retain thermal control materials, such as but not limited to ice, PCM, or the like. Other embodiments may directly integrate the thermal control material into the material used to make the container 3400.

於一個實例中，部件3432之內部3433可由諸如但不限於PCM的熱控制材料填充。可選地，一個實施例可採用諸如但不限於熱電冷卻器等熱控製材料，以冷卻內部。 In one example, the interior 3433 of the component 3432 may be filled with a thermal control material such as but not limited to PCM. Alternatively, one embodiment may use thermal control materials such as but not limited to thermoelectric coolers to cool the interior.

現請參考圖43，現將說明運送容器3500的又一實施例。圖43繪示，運送容器3500可包括蓋3502，用於覆蓋其中特徵和/或樣本器皿。於一些實施例中，蓋3502可包含熱絕緣材料。可選地，蓋3502可包含熱控制單元，以幫助將運送容器3500內部維持於所需溫度範圍。可選地，一些實施例可把蓋3502配置為熱傳導材料，其可用於透過外部熱控制源之熱傳遞，將運送容器3500內部維持於所需溫度範圍。作為非限制性實例，所述熱控制源可為冷卻源、加熱源、熱電熱交換器或其他熱控制裝置。還應暸解，亦可於層3516下的空間3514中包括類似熱控制源，諸如但不限於PCM，或主動冷卻裝置。 Referring now to FIG. 43, another embodiment of the shipping container 3500 will now be described. FIG. 43 illustrates that the shipping container 3500 may include a cover 3502 for covering the features and / or sample vessels therein. In some embodiments, the cover 3502 may include a thermal insulation material. Optionally, the lid 3502 may contain a thermal control unit to help maintain the interior of the shipping container 3500 within a desired temperature range. Optionally, some embodiments may configure the cover 3502 as a thermally conductive material, which may be used for heat transfer through an external heat control source to maintain the interior of the shipping container 3500 within a desired temperature range. As a non-limiting example, the thermal control source may be a cooling source, a heating source, a thermoelectric heat exchanger, or other thermal control devices. It should also be understood that similar thermal control sources, such as but not limited to PCM, or active cooling devices may also be included in the space 3514 under the layer 3516.

應暸解，用於器皿的保持支座3310,3410或其他成型支座可處於與容器分開之片中，或它們可於容器內部一體形成。可選地，特徵3512可為諸如圖41和42中所示托盤3302及3402之一部分。此類托盤可被固定於或可從容器3500中移除。保持機制3520亦可被合併於托盤中，使其能於運送中被固定在位。 It should be understood that the holding supports 3310, 3410 or other shaped supports for the vessels may be in a separate sheet from the container, or they may be integrally formed inside the container. Alternatively, feature 3512 may be part of trays 3302 and 3402 such as shown in FIGS. 41 and 42. Such a tray may be fixed to or removable from the container 3500. The retention mechanism 3520 can also be incorporated into the tray so that it can be fixed in place during transportation.

樣本採集及運送Sample collection and delivery

本文實施例中，係提供用於小體積體液樣本採集或運送之系統和方法。 In the embodiments herein, a system and method for collecting or transporting a small-volume body fluid sample are provided.

於實施例中，包含小體積體液樣本之樣本器皿可被運送。所述樣本及樣本器皿可具有本文他處所述各特徵中任意一個。於實施例中，樣本器皿可包含少於或等於5ml、3ml、4ml、2ml、1.5ml、1ml、750μl、500μl、400μl、300μl、200μl、150μl、100μl、75μl、50μl、40μl、30μl、20μl、10μl或5μl的體液樣本。於實施例中，樣本器皿可具有少於或等於5ml、3ml、4ml、2ml、1.5ml、1ml、750μl、500μl、400μl、300μl、200μl、150μl、100μl、75μl、50μl、40μl、30μl、20μl、10μl或5μl的內部體積。於實施例中，樣本器皿可具有少於或等於5ml、4ml、3ml、2ml、1.5ml、1ml、750μl、500μl、400μl、300μl、200μl、150μl、100μl、75μl、50μl、40μl、30μl、20μl、10μl或5μl的內部體積，且可包含填滿至少10%、20%、30%、40%、50%、60%、70%、80%、90%、95%、98%、99%或100%的器皿內部體積的體液樣本。於實施例中，樣本器皿可被密封，例如採用蓋、帽或膜。本文所述之任意器皿內部尺寸或樣本尺寸可分別適用於密封樣本器皿之內部尺寸或其中樣本之尺寸。於實施例中，密封樣本器皿可具有少於或等於5ml、4ml、3ml、2ml、1.5ml、1ml、750μl、500μl、400 μl、300μl、200μl、150μl、100μl、75μl、50μl、40μl、30μl、20μl、10μl或5μl的內部體積，且可包含填滿至少10%、20%、30%、40%、50%、60%、70%、80%、90%、95%、98%、99%或100%的器皿內部體積的體液樣本，由此少於或等於2ml、1.5ml、1ml、750μl、500μl、400μl、300μl、200μl、150μl、100μl、75μl、50μl、40μl、30μl、20μl、10μl、5μl、4μl、3μl、2μl或1μl的空氣存在於密封器皿之內部體積中。因此，舉例而言，密封樣本器皿可具有少於或等於300μl的內部體積，且可包含填滿至少90%的器皿內部體積的體液樣本，由此少於或等於30ul的空氣存在於密封器皿之內部體積中。於另一實例中，密封樣本器皿可具有少於或等於500μl的內部體積，且可包含填滿至少80%的器皿內部體積的體液樣本，由此少於或等於100ul的空氣存在於密封器皿之內部體積中。於另一實例中，密封樣本器皿可具有少於或等於150μl的內部體積，且可包含填滿至少98%的器皿內部體積的體液樣本，由此少於或等於3ul的空氣存在於密封器皿之內部體積中。 In an embodiment, a sample vessel containing a small volume of body fluid sample can be transported. The sample and sample vessel may have any of the features described elsewhere herein. In an embodiment, the sample vessel may contain less than or equal to 5 ml, 3 ml, 4 ml, 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10μl or 5μl body fluid samples. In an embodiment, the sample vessel may have less than or equal to 5 ml, 3 ml, 4 ml, 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10μl or 5μl internal volume. In an embodiment, the sample vessel may have less than or equal to 5 ml, 4 ml, 3 ml, 2 ml, 1.5 ml, 1 ml, 750 μl, 500 μl, 400 μl, 300 μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10μl or 5μl internal volume, and may contain at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, 98%, 99% or 100% % Of the volume of body fluid in the vessel. In an embodiment, the sample vessel may be sealed, for example using a lid, cap or membrane. The internal dimensions or sample dimensions of any vessel described herein can be adapted to the internal dimensions of the sealed sample vessel or the dimensions of the sample therein, respectively. In an embodiment, the sealed sample vessel may have less than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750μl, 500μl, 400 μl, 300μl, 200μl, 150μl, 100μl, 75μl, 50μl, 40μl, 30μl, 20μl, 10μl or 5μl internal volume, and may include filling at least 10%, 20%, 30%, 40%, 50%, 60% , 70%, 80%, 90%, 95%, 98%, 99% or 100% of the internal volume of the body fluid sample, and thus less than or equal to 2ml, 1.5ml, 1ml, 750μl, 500μl, 400μl, 300μl, 200 μl, 150 μl, 100 μl, 75 μl, 50 μl, 40 μl, 30 μl, 20 μl, 10 μl, 5 μl, 4 μl, 3 μl, 2 μl or 1 μl of air exist in the internal volume of the sealed vessel. Thus, for example, a sealed sample vessel may have an internal volume of less than or equal to 300 μl, and may contain a body fluid sample that fills at least 90% of the internal volume of the vessel, whereby less than or equal to 30 ul of air is present in the sealed vessel In the internal volume. In another example, the sealed sample vessel may have an internal volume of less than or equal to 500 μl, and may include a body fluid sample that fills at least 80% of the internal volume of the vessel, whereby less than or equal to 100 ul of air is present in the sealed vessel In the internal volume. In another example, the sealed sample vessel may have an internal volume of less than or equal to 150 μl, and may contain a body fluid sample that fills at least 98% of the internal volume of the vessel, whereby less than or equal to 3 ul of air is present in the sealed vessel In the internal volume.

於實施例中，包含樣本之樣本器皿亦可包含抗凝劑。所述抗凝劑可溶解於樣本中，或存在於器皿中(舉例而言，乾燥於器皿之一個或多個內表面上，或以固體形態處於器皿底部)。包含樣本之樣本器皿可具有“總抗凝劑含量”，其中所述總抗凝劑含量為存在於器皿內部體積中抗凝劑之總量，並包括溶解於樣本中的抗凝劑(如有的 話)，以及器皿中未溶解於樣本中的抗凝劑(如有的話)。於實施例中，包含樣本之樣本器皿可包含不超過1ml之樣本並具有不超過3mg EDTA之總抗凝劑含量，可包含不超過750μl之樣本並具有不超過2.3mg EDTA之總抗凝劑含量，可包含不超過500μl之樣本並具有不超過1.5mg EDTA之總抗凝劑含量，可包含不超過400μl之樣本並具有不超過1.2mg EDTA之總抗凝劑含量，可包含不超過300μl之樣本並具有不超過0.9mg EDTA之總抗凝劑含量，可包含不超過200μl之樣本並具有不超過0.6mg EDTA之總抗凝劑含量，可包含不超過150μl之樣本並具有不超過0.45mg EDTA之總抗凝劑含量，可包含不超過100μl之樣本並具有不超過0.3mg EDTA之總抗凝劑含量，可包含不超過75μl之樣本並具有不超過0.23mg EDTA之總抗凝劑含量，可包含不超過50μl之樣本並具有不超過0.15mg EDTA之總抗凝劑含量，可包含不超過40μl之樣本並具有不超過0.12mg EDTA之總抗凝劑含量，可包含不超過30μl之樣本並具有不超過0.09mg EDTA之總抗凝劑含量，可包含不超過20μl之樣本並具有不超過0.06mg EDTA之總抗凝劑含量，可包含不超過10μl之樣本並具有不超過0.03mg EDTA之總抗凝劑含量，或可包含不超過5μl之樣本並具有不超過0.015mg EDTA之總抗凝劑含量。於實施例中，包含樣本之樣本器皿可包含不超過1ml之樣本並具有不超過2mg EDTA之總抗凝劑含量，可包含不超過750μl之樣本並具有不超過1.5mg EDTA之總抗凝劑含量，可包含不超過500μl之樣本並具有不超過1mg EDTA之總抗凝劑含量，可包含不超過400μl之樣本並具有不超過0.8mg EDTA之總抗凝劑含量，可包含不超過300μl之樣本並具有不超過0.6mg EDTA之總抗凝劑含量，可包含不超過200μl之樣本並具有不超過0.4mg EDTA之總抗凝劑含量，可包含不超過150μl之樣本並具有不超過0.3mg EDTA之總抗凝劑含量，可包含不超過100μl之樣本並具有不超過0.2mg EDTA之總抗凝劑含量，可包含不超過75μl之樣本並具有不超過0.15mg EDTA之總抗凝劑含量，可包含不超過50μl之樣本並具有不超過0.1mg EDTA之總抗凝劑含量，可包含不超過40μl之樣本並具有不超過0.08mg EDTA之總抗凝劑含量，可包含不超過30μl之樣本並具有不超過0.06mg EDTA之總抗凝劑含量，可包含不超過20μl之樣本並具有不超過0.04mg EDTA之總抗凝劑含量，可包含不超過10μl之樣本並具有不超過0.02mg EDTA之總抗凝劑含量，或可包含不超過5μl之樣本並具有不超過0.01mg EDTA之總抗凝劑含量。於實施例中，包含樣本之樣本器皿可包含不超過1ml之樣本並具有不超過30美國藥典(USP)單位肝磷脂之總抗凝劑含量，可包含不超過750μl之樣本並具有不超過23USP單位肝磷脂之總抗凝劑含量，可包含不超過500μl之樣本並具有不超過15USP單位肝磷脂之總抗凝劑含量，可包含不超過400μl之樣本並具有不超過12USP單位肝磷脂之總抗凝劑含量，可包含不超過300μl之 樣本並具有不超過9USP單位肝磷脂之總抗凝劑含量，可包含不超過200μl之樣本並具有不超過6USP單位肝磷脂之總抗凝劑含量，可包含不超過150μl之樣本並具有不超過4.5USP單位肝磷脂之總抗凝劑含量，可包含不超過100μl之樣本並具有不超過3USP單位肝磷脂之總抗凝劑含量，可包含不超過75μl之樣本並具有不超過2.3USP單位肝磷脂之總抗凝劑含量，可包含不超過50μl之樣本並具有不超過1.5USP單位肝磷脂之總抗凝劑含量，可包含不超過40μl之樣本並具有不超過1.2USP單位肝磷脂之總抗凝劑含量，可包含不超過30μl之樣本並具有不超過0.9USP單位肝磷脂之總抗凝劑含量，可包含不超過20μl之樣本並具有不超過0.6USP單位肝磷脂之總抗凝劑含量，可包含不超過10μl之樣本並具有不超過0.3USP單位肝磷脂之總抗凝劑含量，或可包含不超過5μl之樣本並具有不超過0.15USP單位肝磷脂之總抗凝劑含量。於實施例中，包含樣本之樣本器皿可包含不超過1ml之樣本並具有不超過15USP單位肝磷脂之總抗凝劑含量，可包含不超過750μl之樣本並具有不超過11USP單位肝磷脂之總抗凝劑含量，可包含不超過500μl之樣本並具有不超過7.5USP單位肝磷脂之總抗凝劑含量，可包含不超過400μl之樣本並具有不超過6USP單位肝磷脂之總抗凝劑含量，可包含不超過300μl之樣本並具有不超過4.5USP單位肝磷脂之總抗凝劑含量，可包含不超過200μl之樣本並具有不超過3USP單位肝磷脂之總抗凝劑含量，可包含不超過150μl之 樣本並具有不超過2.3USP單位肝磷脂之總抗凝劑含量，可包含不超過100μl之樣本並具有不超過1.5USP單位肝磷脂之總抗凝劑含量，可包含不超過75μl之樣本並具有不超過1.2USP單位肝磷脂之總抗凝劑含量，可包含不超過50μl之樣本並具有不超過0.75USP單位肝磷脂之總抗凝劑含量，可包含不超過40μl之樣本並具有不超過0.6USP單位肝磷脂之總抗凝劑含量，可包含不超過30μl之樣本並具有不超過0.45USP單位肝磷脂之總抗凝劑含量，可包含不超過20μl之樣本並具有不超過0.3USP單位肝磷脂之總抗凝劑含量，可包含不超過10μl之樣本並具有不超過0.15USP單位肝磷脂之總抗凝劑含量，或可包含不超過5μl之樣本並具有不超過0.08USP單位肝磷脂之總抗凝劑含量。 In an embodiment, the sample vessel containing the sample may also contain an anticoagulant. The anticoagulant can be dissolved in the sample or present in the vessel (for example, dried on one or more inner surfaces of the vessel, or at the bottom of the vessel in solid form). The sample vessel containing the sample may have a "total anticoagulant content", where the total anticoagulant content is the total amount of anticoagulant present in the internal volume of the vessel and includes the anticoagulant dissolved in the sample (if any of Words), and anticoagulant (if any) not dissolved in the sample in the vessel. In an embodiment, the sample vessel containing the sample may contain no more than 1 ml of sample and have a total anticoagulant content of not more than 3 mg EDTA, may contain no more than 750 μl of sample and have a total anticoagulant content of not more than 2.3 mg EDTA , May contain no more than 500μl of samples and have a total anticoagulant content of not more than 1.5mg EDTA, may contain no more than 400μl of samples and have a total anticoagulant content of not more than 1.2mg EDTA, may contain no more than 300μl of samples It has a total anticoagulant content of not more than 0.9 mg EDTA, may contain a sample of not more than 200 μl and has a total anticoagulant content of not more than 0.6 mg EDTA, may contain a sample of not more than 150 μl and has a maximum of 0.45 mg EDTA The total anticoagulant content may contain no more than 100 μl of the sample and has a total anticoagulant content of not more than 0.3 mg EDTA, may contain no more than 75 μl of the sample and has a total anticoagulant content of not more than 0.23 mg EDTA, may contain Samples not exceeding 50 μl and having a total anticoagulant content not exceeding 0.15 mg EDTA, may contain samples not exceeding 40 μl and having a total anticoagulant content not exceeding 0.12 mg EDTA, may containing samples not exceeding 30 μl and having no Total anticoagulant content of more than 0.09mg EDTA, may contain no more than 20μl of samples and has a total anticoagulant content of not more than 0.06mg EDTA, may contain no more than 10μl of samples and has a total anticoagulant of not more than 0.03mg EDTA The content of the agent may contain no more than 5 μl of the sample and have a total anticoagulant content not exceeding 0.015 mg EDTA. In an embodiment, the sample vessel containing the sample may contain no more than 1 ml of sample and have a total anticoagulant content of no more than 2 mg of EDTA, may contain no more than 750 μl of sample and have no more than 1.5 mg The total anticoagulant content of EDTA may contain no more than 500 μl of the sample and have a total anticoagulant content of no more than 1 mg EDTA, may contain no more than 400 μl of the sample and have a total anticoagulant content of no more than 0.8 mg EDTA, may Contains no more than 300μl of samples and has a total anticoagulant content of not more than 0.6mg EDTA, may contain no more than 200μl of samples and has a total anticoagulant content of not more than 0.4mg EDTA, may contain no more than 150μl of samples and has No more than 0.3mg EDTA total anticoagulant content, may contain no more than 100μl sample and have no more than 0.2mg EDTA total anticoagulant content, may contain no more than 75μl sample and have no more than 0.15mg EDTA total resistance The content of the coagulant, which can contain no more than 50μl of the sample and has a total anticoagulant content of not more than 0.1mg EDTA, can contain the no more than 40μl of the sample and has a total anticoagulant content of not more than 0.08mg EDTA, can contain not more than 30μl sample with total anticoagulant content not exceeding 0.06mg EDTA, may contain no more than 20μl sample and having total anticoagulant content not exceeding 0.04mg EDTA, may contain no more than 10μl sample and has not exceeding 0.02 The total anticoagulant content of mg EDTA may contain no more than 5 μl of the sample and have a total anticoagulant content of not more than 0.01 mg EDTA. In an embodiment, a sample vessel containing a sample may contain no more than 1 ml of sample and have a total anticoagulant content of no more than 30 USP units of heparin, and may contain no more than 750 μl of a sample and have no more than 23 USP units The total anticoagulant content of heparin may contain no more than 500 μl of the sample and have a total anticoagulant content of not more than 15 USP units of heparin, and may contain no more than 400 μl of the sample and have a total anticoagulant of no more than 12 USP units of heparin The content of the agent may contain no more than 300μl The sample has a total anticoagulant content of not more than 9 USP units of heparin, may contain no more than 200 μl of the sample and has a total anticoagulant content of not more than 6 USP units of heparin, may contain no more than 150 μl of the sample and has no more than 4.5 The total anticoagulant content of USP units of heparin may contain no more than 100 μl of samples and have a total anticoagulant content of not more than 3 USP units of heparin, may contain no more than 75 μl of samples and have a total of 2.3 USP units of heparin Total anticoagulant content, which can contain no more than 50μl of samples and has a total anticoagulant content of not more than 1.5USP units of heparin, and can contain no more than 40μl of sample and has a total anticoagulant of not more than 1.2USP units of heparin Content, may contain no more than 30μl of samples and have a total anticoagulant content of not more than 0.9USP units of heparin, may contain no more than 20μl of sample and have a total anticoagulant content of not more than 0.6USP of heparin, may contain Samples not exceeding 10 μl have a total anticoagulant content not exceeding 0.3 USP units of heparin, or may contain samples not exceeding 5 μl and having a total anticoagulant content not exceeding 0.15 USP units of heparin. In an embodiment, the sample vessel containing the sample may contain no more than 1 ml of sample and have a total anticoagulant content of no more than 15 USP units of heparin, and may contain a no more than 750 μl of sample and have a total resistance of no more than 11 USP of heparin The content of the coagulant may include no more than 500μl of the sample and have a total anticoagulant content of not more than 7.5USP units of heparin, and may contain no more than 400μl of the sample and have a total anticoagulant content of not more than 6USP of heparin. Contains no more than 300μl of the sample and has a total anticoagulant content of not more than 4.5USP units of heparin, may contain no more than 200μl of the sample and has a total anticoagulant content of not more than 3USP of heparin, may contain no more than 150μl of The sample has a total anticoagulant content of not more than 2.3 USP units of heparin, may contain no more than 100 μl of the sample and has a total anticoagulant content of not more than 1.5 USP units of heparin, may contain no more than 75 μl of the sample and has no Total anticoagulant content of heparin above 1.2USP units, may contain no more than 50μl of sample and have total anticoagulant content of not more than 0.75USP unit heparin, may contain no more than 40μl of sample and have no more than 0.6USP unit The total anticoagulant content of heparin may contain no more than 30 μl of the sample and have a total anticoagulant content of not more than 0.45 USP units of heparin, and may contain no more than 20 μl of the sample and have a total of 0.3 USP units of heparin Anticoagulant content, may contain no more than 10 μl of the sample and have a total anticoagulant content of no more than 0.15 USP units of heparin, or may contain no more than 5 μl of the sample and have a total anticoagulant of no more than 0.08 USP units of heparin content.

於實施例中，可獲得或運送兩個或更多個包含採自單個對象之樣本的樣本器皿。當獲得或運送兩個或更多個包含採自單個對象之樣本的樣本器皿時，該兩個或更多個樣本器皿可被置於一個容器中儲存或運送，該容器包含或不包含採自其他對象之樣本。於實施例中，可獲得或運送至少2、3、4、5、6、7、8、9或10個包含採自單個對象之樣本的樣本器皿。於實施例中，可獲得或運送不超過2、3、4、5、6、7、8、9或10個包含採自單個對象之樣本的樣本器皿。於實施例中，可獲得或運送至少2、3、4、5、6、7、8或9個樣本器皿且不超過3、4、5、6、7、8、9或10個包含採自單個對象之樣本的樣本器皿。於涉及 兩個或更多個包含採自同一對象之樣本的樣本器皿的實施例中，各樣本器皿中的樣本可於相同或不同時間採自一個對象。於涉及兩個或更多個包含採自同一對象之樣本的樣本器皿的一些實施例中，各樣本器皿中的樣本可採自對象的同一位置或來源點。舉例而言，可獲得兩個包含採自同一對象之全血的樣本器皿，其中樣本器皿兩者皆包含採自同一手指位置之全血。於涉及兩個或更多個包含採自同一對象之樣本的樣本器皿的其他實施例中，各樣本器皿中的樣本可採自對象的不同位置/來源點。舉例而言，可獲得兩個包含採自同一對象之全血的樣本器皿，其中一個樣本器皿包含採自第一手指位置之全血(舉例而言，位於第一個手指)，第二個樣本器皿包含採自第二手指位置之全血(舉例而言，位於第二個手指)。於涉及兩個或更多個包含採自單個對象之樣本的樣本器皿的實施例中，該兩個或更多個樣本器皿可包含不同類型的抗凝劑或其他血液添加劑。舉例而言，第一樣本器皿可包括全血及EDTA，第二樣本器皿可包含全血及肝磷脂，其中樣本採自同一對象。於另一實例中，第一和第二樣本器皿可包括全血及EDTA，第三樣本器皿可包含全血及肝磷脂，其中樣本採自同一對象。於另一實例中，第一樣本器皿可包括全血及EDTA，第二樣本器皿可包括全血及肝磷脂，第三樣本器皿可包含全血及檸檬酸鈉，其中樣本採自同一對象。於涉及兩個或更多個包含採自單個對象之樣本的樣本器皿的實施例中，該兩個或更多個樣本器皿可包含採自對象之不同 類型的樣本。舉例而言，第一樣本器皿可包括全血，第二樣本器皿可包括採自同一對象之血漿。於另一實例中，第一樣本器皿可包括全血，第二樣本器皿可包括採自同一對象之尿樣。於另一實例中，第一和第二樣本器皿可包括全血，第三樣本器皿可包括採自同一對象之唾液。 In an embodiment, two or more sample vessels containing samples taken from a single subject can be obtained or shipped. When two or more sample vessels containing samples taken from a single subject are obtained or shipped, the two or more sample vessels can be placed in a container for storage or transportation, with or without Samples of other objects. In an embodiment, at least 2, 3, 4, 5, 6, 7, 8, 9, or 10 sample vessels containing samples taken from a single subject may be obtained or shipped. In an embodiment, no more than 2, 3, 4, 5, 6, 7, 8, 9, or 10 sample vessels containing samples taken from a single subject can be obtained or shipped. In embodiments, at least 2, 3, 4, 5, 6, 7, 8, or 9 sample vessels can be obtained or shipped and no more than 3, 4, 5, 6, 7, 8, 9, or 10 including Sample containers for samples of individual objects. Involved in In an embodiment of two or more sample vessels containing samples taken from the same subject, the samples in each sample vessel may be taken from one subject at the same or different times. In some embodiments involving two or more sample vessels containing samples taken from the same subject, the samples in each sample vessel may be taken from the same location or source point of the subject. For example, two sample vessels containing whole blood collected from the same subject can be obtained, where both sample vessels contain whole blood collected from the same finger position. In other embodiments involving two or more sample vessels containing samples taken from the same subject, the samples in each sample vessel may be taken from different locations / source points of the subject. For example, two sample vessels containing whole blood collected from the same subject can be obtained, where one sample vessel contains whole blood collected from the position of the first finger (for example, located on the first finger), and the second sample The vessel contains whole blood collected from the position of the second finger (for example, located on the second finger). In embodiments involving two or more sample vessels containing samples taken from a single subject, the two or more sample vessels may contain different types of anticoagulants or other blood additives. For example, the first sample vessel may include whole blood and EDTA, and the second sample vessel may include whole blood and heparin, where the samples are taken from the same subject. In another example, the first and second sample vessels can include whole blood and EDTA, and the third sample vessel can include whole blood and heparin, where the samples are taken from the same subject. In another example, the first sample vessel may include whole blood and EDTA, the second sample vessel may include whole blood and heparin, and the third sample vessel may include whole blood and sodium citrate, where the samples are taken from the same subject. In embodiments involving two or more sample vessels containing samples taken from a single subject, the two or more sample vessels may contain different samples taken from the subject Type of sample. For example, the first sample vessel may include whole blood, and the second sample vessel may include plasma collected from the same subject. In another example, the first sample vessel may include whole blood, and the second sample vessel may include urine samples taken from the same subject. In another example, the first and second sample vessels may include whole blood, and the third sample vessel may include saliva collected from the same subject.

於本文提供之系統及方法中，可從對象獲取一定總體積之體液樣本。該總體積之體液樣本可被傳遞入單個樣本器皿，或兩個或多個樣本器皿中。舉例而言，可從對象獲取總體積為500微升之體液樣本，且其被傳遞入單個樣本器皿中，其中該單個樣本器皿具有600微升之最大內部體積。於另一實例中，可從對象獲取總體積為500微升之體液樣本，且其被傳遞入兩個樣本器皿中，其中各樣本器皿具有300微升之最大內部體積。於另一實例中，可從對象獲取總體積為500微升之體液樣本，且其被傳遞入兩個樣本器皿中，其中一個樣本器皿具有400微升之最大內部體積，而另一個樣本器皿具有100微升之最大內部體積。於本文提供之系統及方法中，可從對象獲取總體積少於或等於5ml、4ml、3ml、2ml、1.5ml、1ml、750μl、500μl、400μl、300μl、200μl、150μl、100μl、75μl、50μl、40μl、30μl、20μl、10μl、5μl或1μl之體液樣本。採自對象之該總體積的體液樣本可被分開加入1、2、3、4、5、6、7、8、9、10或更多個樣本器皿中，如本文他處所述。當從對象獲取一定總體積之體液樣本被分開加入兩個或多個樣本器皿中時，於一些或全部 所述不同樣本器皿中的該總體積之體液樣本的各部分可包含不同的抗凝劑或其他添加劑。舉例而言，可從對象獲取總體積為500微升之體液樣本，且其被傳遞入兩個樣本器皿中，其中一個樣本器皿含有與EDTA混合之250微升體液樣本，而另一個樣本器皿則含有與肝磷脂混合之250微升體液樣本。通常如本文中用法，一定總體積之體液樣本指單個類型之體液樣本--例如全血或尿樣或唾液等。 In the system and method provided herein, a total volume of body fluid samples can be obtained from the subject. The total volume of body fluid sample can be transferred into a single sample vessel, or two or more sample vessels. For example, a body fluid sample with a total volume of 500 microliters can be taken from the subject and transferred into a single sample vessel, where the single sample vessel has a maximum internal volume of 600 microliters. In another example, a body fluid sample with a total volume of 500 microliters can be taken from the subject and it is transferred into two sample vessels, where each sample vessel has a maximum internal volume of 300 microliters. In another example, a body fluid sample with a total volume of 500 microliters can be obtained from the subject and it is transferred into two sample vessels, one of which has a maximum internal volume of 400 microliters, while the other sample vessel has The maximum internal volume of 100 microliters. In the system and method provided herein, a total volume less than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750μl, 500μl, 400μl, 300μl, 200μl, 150μl, 100μl, 75μl, 50μl, 40μl, 30μl, 20μl, 10μl, 5μl or 1μl body fluid samples. The total volume of body fluid sample taken from the subject can be added separately to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more sample vessels, as described elsewhere herein. When a total volume of body fluid samples obtained from a subject is added separately to two or more sample vessels, some or all The portions of the total volume of body fluid samples in the different sample vessels may contain different anticoagulants or other additives. For example, a body fluid sample with a total volume of 500 μl can be obtained from the subject and it is transferred into two sample vessels, one of which contains 250 μl of body fluid sample mixed with EDTA, while the other sample vessel Contains 250 microliters of body fluid sample mixed with heparin. Usually as used in this article, a total volume of body fluid sample refers to a single type of body fluid sample-such as whole blood or urine or saliva.

於實施例中，包含全血之樣本器皿可於儲存或運送前加以離心分離，使得全血於被運送前在樣本器皿中被分為血漿及細胞團。於其他實施例中，包含全血之樣本器皿於儲存或運送前不加以離心分離。 In an embodiment, the sample vessel containing whole blood may be centrifuged before storage or transportation, so that the whole blood is separated into plasma and cell mass in the sample vessel before being transported. In other embodiments, the sample vessel containing whole blood is not centrifuged before storage or transportation.

於本文提供之一些系統及方法實施例中，可於採集後及運送前乾燥體液樣本。於實施例中，經乾燥樣本稍後可復原為液體形態，如於分析或處理樣本時。 In some system and method embodiments provided herein, the body fluid sample can be dried after collection and before delivery. In an embodiment, the dried sample can be restored to a liquid form later, such as when analyzing or processing the sample.

於本文提供之一些系統及方法實施例中，樣本器皿可被從第一位置運送至第二位置。第一位置可為從對象採集樣本之位置，而第二位置可為執行一步或多步樣本處理或分析步驟之位置。樣本及樣本器皿可具有本文他處所述各特徵中任意一個。舉例而言，樣本可處於非吸收、未添加基質之液體形態。樣本器皿可置於本文所述運送容器或其他結構中加以運送。舉例而言，樣本器皿可處於袋、包、信封、盒、膠囊或其他結構中加以運送。於實施例中，所述第一位置及第二位置可處於同一房間、建築物、場地或建築物群中。於實施例中，第一位置及第二位 置可彼此相隔至少1米、5米、10米、50米、100米、500米、1公里、5公里、10公里、15公里、20公里、30公里、50公里、100公里或500公里。於實施例中，第一位置及第二位置可彼此相隔不超過5米、10米、50米、100米、500米、1公里、5公里、10公里、15公里、20公里、30公里、50公里、100公里、500公里或1000公里。於實施例中，第一位置及第二位置可彼此相隔至少1米、5米、10米、50米、100米、500米、1公里、5公里、10公里、15公里、20公里、30公里、50公里、100公里或500公里且不超過5米、10米、50米、100米、500米、1公里、5公里、10公里、15公里、20公里、30公里、50公里、100公里、500公里或1000公里。於第一位置為從對象採集樣本之位置的實施例中，樣本器皿可於從對象採集樣本後48小時、36小時、24小時、12小時、8小時、6小時、4小時、3小時、2小時、1小時、45分鐘、30分鐘、15分鐘、10分鐘、5分鐘、1分鐘或30秒內從第一位置運送至第二位置。 In some system and method embodiments provided herein, the sample vessel can be transported from the first location to the second location. The first location may be the location where the sample is collected from the subject, and the second location may be the location where one or more sample processing or analysis steps are performed. The sample and sample vessel may have any of the features described elsewhere herein. For example, the sample can be in a non-absorbent, non-matrix added liquid form. Sample vessels can be placed in shipping containers or other structures described herein for shipping. For example, the sample vessel can be transported in a bag, bag, envelope, box, capsule, or other structure. In an embodiment, the first location and the second location may be in the same room, building, venue, or group of buildings. In the embodiment, the first position and the second position They can be separated from each other by at least 1 m, 5 m, 10 m, 50 m, 100 m, 500 m, 1 km, 5 km, 10 km, 15 km, 20 km, 30 km, 50 km, 100 km or 500 km. In an embodiment, the first position and the second position may be separated from each other by no more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometers, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 kilometers, 500 kilometers or 1000 kilometers. In an embodiment, the first position and the second position may be separated from each other by at least 1 m, 5 m, 10 m, 50 m, 100 m, 500 m, 1 km, 5 km, 10 km, 15 km, 20 km, 30 Kilometers, 50 kilometers, 100 kilometers or 500 kilometers and no more than 5 meters, 10 meters, 50 meters, 100 meters, 500 meters, 1 kilometers, 5 kilometers, 10 kilometers, 15 kilometers, 20 kilometers, 30 kilometers, 50 kilometers, 100 Kilometers, 500 kilometers or 1000 kilometers. In the embodiment where the first position is where the sample is collected from the subject, the sample vessel can be 48 hours, 36 hours, 24 hours, 12 hours, 8 hours, 6 hours, 4 hours, 3 hours, 2 hours after the sample is collected from the subject Shipping from the first location to the second location within hours, 1 hour, 45 minutes, 30 minutes, 15 minutes, 10 minutes, 5 minutes, 1 minute or 30 seconds.

如本文用法，“樣本接收地點”為可接收經運送之樣本的地方，且於該處，可針對該樣本執行一步或多步步驟。舉例而言，抵達樣本接收地點之樣本可於樣本接收地點加以處理、分析或操作，例如作為樣本測試或化驗之一部分。舉例而言，樣本可處於本文所述任意器皿或裝置中加以運送。於實施例中，樣本接收地點可包含一個或 多個樣本處理裝置，其可用於處理或分析樣本。舉例而言，樣本處理裝置可如2011年9月26日提交之美國專利申請案第13/244,947號或本文他處經引用而合併之任意其他文件中所述。於樣本自樣本採集地點運送至樣本接收地點過程中，樣本可通過任意數目之地點。於實施例中，第一地點可為樣本採集地點，第二地點可為樣本接收地點。 As used herein, a "sample receiving location" is a place where a shipped sample can be received, and there, one or more steps can be performed for the sample. For example, samples arriving at the sample receiving location can be processed, analyzed, or manipulated at the sample receiving location, for example, as part of sample testing or testing. For example, the sample can be transported in any vessel or device described herein. In an embodiment, the sample receiving location may include one or Multiple sample processing devices that can be used to process or analyze samples. For example, the sample processing device may be as described in US Patent Application No. 13 / 244,947 filed on September 26, 2011, or any other document incorporated by reference elsewhere in this document. As the sample is transported from the sample collection location to the sample reception location, the sample can pass through any number of locations. In an embodiment, the first location may be a sample collection location, and the second location may be a sample reception location.

現請參考圖44，現將說明體液樣本採集及運送之實施例。圖44繪示位於對象皮膚表面S上的一個體液樣本B。於圖44之非限制性實例中，體液樣本B可籍由多種裝置之一加以採集。作為非限制性實例，採集裝置3530可為但不限於2012年9月6日提交之美國專利申請案第61/697,797號所述之裝置，其籍由引用合併於此以用於所有目的。於此實施例中，體液樣本B係透過一條或多條毛細通道得以採集，並隨後引導至樣本器皿3540。作為非限制性實例，至少一個樣本器皿3540內部可具有最初處於用於抽取體液樣本進入樣本器皿3540之部分真空。一些實施例可同時自樣本採集裝置中相同或不同採集通道抽取樣本採集裝置中的樣本進入樣本器皿3540中。可選地，一些實施例可同時抽取樣本進入樣本器皿中。 Referring now to FIG. 44, an embodiment of body fluid sample collection and transportation will now be described. FIG. 44 shows a body fluid sample B on the skin surface S of the subject. In the non-limiting example of FIG. 44, the body fluid sample B can be collected by one of various devices. As a non-limiting example, the collection device 3530 may be, but not limited to, the device described in US Patent Application No. 61 / 697,797 filed on September 6, 2012, which is hereby incorporated by reference for all purposes. In this embodiment, the body fluid sample B is collected through one or more capillary channels and then guided to the sample vessel 3540. As a non-limiting example, the interior of the at least one sample vessel 3540 may have a partial vacuum initially used to draw a body fluid sample into the sample vessel 3540. Some embodiments may simultaneously draw samples from the sample collection device into the sample vessel 3540 from the same or different collection channels in the sample collection device. Alternatively, some embodiments may draw samples into the sample vessel at the same time.

於本實施例中，當體液樣本處於樣本器皿3540中後，位於其支座3542(或可選地，從其支座3542移除)之樣本器皿3540被載入運送容器3500。於本實施例中，係設有一條或多條槽，其尺寸大小適宜樣本器皿支座3542或適宜於運送容器3500中的樣本器皿槽。作為非限 制性實例，其可以陣列構架容置樣本器皿，並定位成垂直或一些其他預定定位。應暸解，樣本器皿3540的一些實施例被配置為於各器皿中容置不同量之樣本。作為非限制性實例，可基於各樣本器皿中的真空力值、採集裝置之樣本採集通道中所採集樣本量和/或其他因子對此加以控制。可選地，諸如但不限於不同抗凝劑或類似物等各種前處理亦可存在於樣本器皿中。 In this embodiment, after the body fluid sample is in the sample vessel 3540, the sample vessel 3540 located in its support 3542 (or optionally removed from its support 3542) is loaded into the transport container 3500. In this embodiment, one or more slots are provided, the size of which is suitable for the sample vessel support 3542 or the sample vessel slot in the transport container 3500. As non-limited As an example, it can accommodate sample vessels in an array frame and be positioned vertically or some other predetermined position. It should be appreciated that some embodiments of the sample vessel 3540 are configured to contain different amounts of sample in each vessel. As a non-limiting example, this can be controlled based on the vacuum force value in each sample vessel, the sample volume collected in the sample collection channel of the collection device, and / or other factors. Optionally, various pretreatments such as but not limited to different anticoagulants or the like may also be present in the sample vessel.

如圖44所示，樣本器皿3540於諸如但不限於樣本採集地點的第一位置採集樣本。作為非限制性實例，體液樣本隨後於運送容器3500中被運送至第二位置，諸如但不限於接收地點，諸如但不限於分析地點。運送方法可為快件、郵件遞送或其它運送技術。於很多實施例中，可籍由容納運送容器於其中的另一容器完成所述運送。於一個實施例中，樣本採集地點可為護理點。可選地，樣本採集地點可為服務點。可選地，樣本採集地點可為遠離樣本分析地點。 As shown in FIG. 44, the sample vessel 3540 collects samples at a first location such as, but not limited to, a sample collection location. As a non-limiting example, the body fluid sample is then transported in the transport container 3500 to a second location, such as but not limited to a receiving location, such as but not limited to an analysis location. The shipping method may be express, mail delivery, or other shipping technologies. In many embodiments, the shipping can be accomplished by another container that contains the shipping container. In one embodiment, the sample collection location may be a point of care. Alternatively, the sample collection location may be a service point. Alternatively, the sample collection location may be remote from the sample analysis location.

儘管圖44之本實施例繪示體液樣本採自對象表面，其他替代實施例可運用採集技術自對象其他區域採集樣本，如靜脈穿刺，進而裝滿樣本器皿3540。並不排除此類其他採集技術作為表面採集之替代或與其共同使用。表面採集可位於對象之外表面。可選地，一些實施例可自對象內部之易進入表面採集。這些表面上體液樣本B之存在可為自然產生或可透過產生傷口或其他使體液表面可進入的技術。 Although this embodiment of FIG. 44 shows that the body fluid sample is taken from the surface of the subject, other alternative embodiments may use a collection technique to collect samples from other areas of the subject, such as venipuncture, and then fill the sample vessel 3540. It is not excluded that such other collection techniques are used as an alternative to or in conjunction with surface collection. Surface acquisition can be located on the surface outside the object. Alternatively, some embodiments may collect from a surface easily accessible inside the object. The presence of the body fluid sample B on these surfaces may be naturally occurring or permeable to create wounds or other techniques to make the body fluid surface accessible.

現請參考圖45，其繪示另一實施例，其中相對於採集聚於對象表面之樣本，體液樣本可從對象內部採集。圖45實施例繪示採集裝置3550，其具有配置為採集包括但不限於靜脈血液等體液樣本之皮下注射針頭3552。於一個實施例中，體液樣本可填充裝置3550中室3554，其時樣本器皿3540可被接合，以抽取樣本進入各自器皿中。可選地，一些實施例可不具有室3554，與之相反，除用於自針頭3552引導樣本至樣本器皿3540之通道、路徑或管外，具有極小空間。對於諸如血液等體液樣本，血液器皿中壓力可為，血樣並不需要採集裝置提供幫助即可填滿室554。此類實施例可選地包括一個或多個排氣口，諸如但不限於端口，使得空氣於採集裝置中通道被樣本填滿時能夠排出。 Refer now to FIG. 45, which illustrates another embodiment in which a body fluid sample can be collected from inside the object relative to the sample collected on the surface of the object. The embodiment of FIG. 45 illustrates a collection device 3550 having a hypodermic needle 3552 configured to collect samples of bodily fluids including but not limited to venous blood. In one embodiment, the body fluid sample may fill the middle chamber 3554 of the device 3550, at which time the sample vessel 3540 may be engaged to draw the sample into the respective vessel. Optionally, some embodiments may not have a chamber 3554, in contrast, with minimal space except for the channels, paths, or tubes used to guide the sample from the needle 3552 to the sample vessel 3540. For body fluid samples such as blood, the pressure in the blood vessel may be such that the blood sample can fill the chamber 554 without the assistance of the collection device. Such embodiments optionally include one or more exhaust ports, such as but not limited to ports, so that air can be exhausted when the channel in the collection device is filled with the sample.

所述實施例中至少一些或全部均可具有填充指示器，諸如但不限於觀察窗口或開口，其顯示樣本何時出現於採集裝置中，並由此指示可與樣本器皿3540接合。可選地，並未排除不具有填充指示器之實施例。當所需填充程度達到後，已填滿之樣本器皿3540可從樣本採集裝置上分離。可選地，額外樣本器皿3540可與樣本採集裝置3550(或530)接合，以採集額外數量之體液樣本。 At least some or all of the described embodiments may have a fill indicator, such as, but not limited to, a viewing window or opening, which shows when the sample appears in the collection device, and thus indicates that the sample vessel 3540 can be engaged. Optionally, embodiments without fill indicators are not excluded. When the required filling level is reached, the filled sample vessel 3540 can be separated from the sample collection device. Optionally, the additional sample vessel 3540 can be engaged with the sample collection device 3550 (or 530) to collect an additional number of body fluid samples.

圖46繪示樣本採集裝置3570又一實施例。本文所述此實施例具有組織穿刺部分3572，諸如但不限於具有操作部分3574之皮下注射針頭。操作部分3574可促進組織穿刺部分3572之定位，以更精確地進入病患，抵達所 需深度及位置。於本實施例中，樣本採集器皿3540處於載體3576中，其不與組織穿刺部分3572直接物理接觸。可採用諸如但不限於柔性管之液體連接路徑3578連接組織穿刺部分3572及樣本採集器皿3540。一些實施例具有樣本採集器皿3540，其經使用者控制，可滑動至僅與組織穿刺部分3572形成液體連通。所述實施例中至少一些或全部均可具有填充指示器，諸如但不限於觀察窗口或開口，其顯示樣本何時出現於採集裝置中，並由此指示可與樣本器皿3540接合。可選地，並未排除不具有填充指示器之實施例。一些實施例可選地包括一個或多個排氣口，諸如但不限於端口，使得空氣於採集裝置中通道被樣本填滿時能夠排出。於多數實施例中，當所需填充程度達到後，已填滿之樣本器皿3540可從樣本採集裝置上分離。可選地，額外樣本器皿3540可與樣本採集裝置3570接合，以採集額外數量之體液樣本。 FIG. 46 illustrates another embodiment of the sample collection device 3570. This embodiment described herein has a tissue-piercing portion 3572, such as but not limited to a hypodermic needle with an operating portion 3574. The operation part 3574 can promote the positioning of the tissue puncture part 3572 to more accurately enter the patient and reach the place Need depth and location. In this embodiment, the sample collection vessel 3540 is in the carrier 3576, which is not in direct physical contact with the tissue-piercing portion 3572. A liquid connection path 3578 such as but not limited to a flexible tube may be used to connect the tissue-piercing portion 3572 and the sample collection vessel 3540. Some embodiments have a sample collection vessel 3540 which, under user control, can be slid into only liquid communication with the tissue-piercing portion 3572. At least some or all of the described embodiments may have a fill indicator, such as, but not limited to, a viewing window or opening, which shows when the sample appears in the collection device, and thus indicates that the sample vessel 3540 can be engaged. Optionally, embodiments without fill indicators are not excluded. Some embodiments optionally include one or more exhaust ports, such as but not limited to ports, so that air can be exhausted when the channel in the collection device is filled with the sample. In most embodiments, when the required filling level is reached, the filled sample vessel 3540 can be separated from the sample collection device. Optionally, an additional sample vessel 3540 can be engaged with the sample collection device 3570 to collect an additional number of body fluid samples.

樣本處理Sample processing

現請參考圖47，其繪示運送容器3500之系統視圖，其於抵達目的地後，籍由卸載組合3600卸載其內容物。於一個實施例中，當蓋3502位於打開位置，容器3500中樣本器皿可從其中移除。作為非限制性實例，可籍由移除整個樣本器皿托盤、從托盤中移除多個樣本器皿支座和/或籍由移除單個樣本器皿，完成此移除。一些實施例可採用自動控制結構3602，其如箭頭3604所示垂直移動和/或如箭頭3606所示沿構台3608水平移動，從而將樣 本器皿自容器3500中移除。可採用可程式處理器3610控制用於操縱樣本器皿的結構3602之位置。於一個實施例中，結構3602包括磁鐵，用於接合保持機制，以將托盤自結構3602中移除。運用自動臂和/或其他類型可程式機械手之其他實施例可被配置用於本文所述用途，其並未被排除。 Referring now to FIG. 47, which shows a system view of the shipping container 3500, after arriving at the destination, the contents are unloaded by the unloading combination 3600. In one embodiment, when the lid 3502 is in the open position, the sample vessel in the container 3500 can be removed therefrom. As a non-limiting example, this removal can be accomplished by removing the entire sample vessel tray, removing multiple sample vessel supports from the tray, and / or by removing a single sample vessel. Some embodiments may employ an automatic control structure 3602, which moves vertically as indicated by arrow 3604 and / or moves horizontally along the gantry 3608 as indicated by arrow 3606, thereby This vessel is removed from the container 3500. A programmable processor 3610 can be used to control the position of the structure 3602 for manipulating the sample vessel. In one embodiment, the structure 3602 includes a magnet for engaging a retention mechanism to remove the tray from the structure 3602. Other embodiments using robotic arms and / or other types of programmable robots may be configured for the uses described herein, which are not excluded.

於實施例中，當包含樣本之樣本器皿抵達樣本處理或分析位置時，該樣本可被移除出樣本器皿。樣本器皿可於樣本被移除出樣本器皿前加以處理(舉例而言，搖動、旋轉、混合或離心)。可籍由任意合適機制，諸如抽吸(例如籍由液體處理系統或吸量管)、傾倒或機械力(舉例而言，籍由減少樣本器皿內部區域之尺寸，強制樣本離開器皿)，將樣本移除出樣本器皿。於實施例中，當樣本被移除出樣本器皿時，很少或無樣本殘留於器皿中(舉例而言，作為機械/傳遞損失)。舉例而言，當樣本被移除出樣本器皿後，少於或等於50μl、40μl、30μl、20μl、15μl、10μl、5μl、4μl、3μl、2μl、1μl或0μl樣本可殘留於器皿中。 In an embodiment, when the sample vessel containing the sample arrives at the sample processing or analysis location, the sample can be removed from the sample vessel. The sample vessel can be processed before being removed from the sample vessel (for example, shaking, rotating, mixing or centrifuging). The sample can be removed by any suitable mechanism, such as aspiration (eg, by a liquid handling system or pipette), pouring, or mechanical force (for example, by reducing the size of the internal area of the sample vessel, forcing the sample to leave the vessel) Remove the sample vessel. In an embodiment, when the sample is removed from the sample vessel, little or no sample remains in the vessel (for example, as a mechanical / transfer loss). For example, when the sample is removed from the sample vessel, less than or equal to 50 μl, 40 μl, 30 μl, 20 μl, 15 μl, 10 μl, 5 μl, 4 μl, 3 μl, 2 μl, 1 μl, or 0 μl of the sample may remain in the vessel.

作為非限制性實例，隨後可採用諸如2011年9月26日提交之美國專利申請案第13/244,947號所述系統，其籍由引用合併於此以用於所有目的，處理樣本器皿中的樣本。可按2011年9月26日提交之美國專利申請案第13/244,946號(其籍由引用合併於此以用於所有目的)所述CLIA合規方式配置所述分析系統。於實施例中，依照 本文所提供系統或方法運送之樣本可於抵達處理或分析位置後，分為兩個或更多個較小部分，並可對樣本進行各種分析。舉例而言，於實施例中，可對依照本文所提供系統或方法運送之樣本進行至少1、2、3、4、5、6、7、8、9、10、20、30、40或50種分析。所述分析可包括不同類型之分析(舉例而言，蛋白質、核酸或細胞分析)，並採用一種或多種檢測方法(例如細胞分析、冷光或基於分光光度計)。於實施例中，可運送兩個或更多個包含採自單個對象之樣本的樣本器皿，其中所述兩個或更多個樣本器皿包含至少兩種與樣本混合之抗凝劑(舉例而言，一個樣本器皿包含EDTA-樣本，而另一個樣本器皿包含肝磷脂-樣本)。來自EDTA-樣本器皿之樣本隨後可被用於對肝磷脂敏感或EDTA不敏感的一種或多種分析。同樣地，來自肝磷脂-樣本器皿之樣本隨後可被用於對EDTA敏感或肝磷脂不敏感的一種或多種分析。於實施例中，依本文所提供系統及方法運送之樣本可於抵達目的地後，分為兩個或更多個部分，並於1、2、3、4、5、6、7、8、9、10或更多個不同樣本分析儀上進行分析。 As a non-limiting example, a system such as that described in US Patent Application No. 13 / 244,947 filed on September 26, 2011, which is hereby incorporated by reference for all purposes, can process samples in sample vessels . The analysis system can be configured in a CLIA-compliant manner as described in US Patent Application No. 13 / 244,946 filed on September 26, 2011 (which is hereby incorporated by reference for all purposes). In the embodiment, according to The sample transported by the system or method provided herein can be divided into two or more smaller parts after reaching the processing or analysis location, and various analysis can be performed on the sample. For example, in an embodiment, at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, or 50 may be performed on samples shipped in accordance with the systems or methods provided herein Kind of analysis. The analysis may include different types of analysis (for example, protein, nucleic acid, or cell analysis) and use one or more detection methods (eg, cell analysis, luminescence, or spectrophotometer-based). In an embodiment, two or more sample vessels containing samples taken from a single subject may be shipped, wherein the two or more sample vessels contain at least two anticoagulants mixed with the sample (for example , One sample vessel contains the EDTA-sample, and the other sample vessel contains the heparin-sample). The sample from the EDTA-sample vessel can then be used for one or more analyses that are sensitive to heparin or insensitive to EDTA. Similarly, samples from heparin-sample vessels can then be used for one or more analyses that are sensitive to EDTA or insensitive to heparin. In the embodiment, the samples transported according to the system and method provided herein can be divided into two or more parts after arriving at the destination, and the samples can be sent to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more different sample analyzers for analysis.

現請參考圖49至51，應暸解，運用依照本文所提供系統或方法準備或運送之採自對象的樣本，可執行清單(圖49至51)中至少任意兩項測試。舉例而言，可對採自對象的體液樣本執行清單中至少兩項測試，其中用於執行所述測試的體液樣本總體積不超過300微升，且所述採自對象的體液樣本總體積以液體形態於具有400微升或更 小之內部體積的樣本器皿中加以運送。於另一實例中，可對採自對象的體液樣本執行清單中至少兩項測試，其中用於執行所述測試的體液樣本總體積不超過300微升，且所述採自對象的體液樣本總體積以液體形態於第一樣本器皿和第二樣本器皿中加以運送，各器皿具有200微升或更小之內部體積，第一樣本器皿包含與第一抗凝劑混合之體液樣本，而第二樣本器皿包含與第二抗凝劑混合之體液樣本。於實施例中，對總體積不大於或等於5ml,4ml,3ml,2ml,1.5ml,1ml,750μl,500μl,400μl,300μl,200μl,150μl,100μl,75μl,50μl,40μl,30μl,20μl,10μl,5μl或1μl的採自對象之體液樣本，可執行清單(圖49至51)中至少2,3,4,5,6,7,8,9,10,11,12,13,14,15,20,25,30,35,40,50或60項測試。所述體液樣本總體積可於單個樣本器皿中儲存或自採集地點被運送至分析或處理位置，或其可被分開置於2,3,4,5,6,7,8,9,10,11,12,13,14,15,20,25或更多個樣本器皿中。當採自單個對象之體液樣本總體積被分開置於兩個或更多個樣本器皿中時，一些或各所述樣本器皿中的樣本部分可包含一種不同抗凝劑或其他添加劑。於一個實例中，總體積不超過300微升之採自對象的體液樣本可被用於執行兩項或更多項測試，其中所述不超過300微升的樣本之至少一部分與第一抗凝劑混合，所述不超過300微升的樣本之第二部分與不同於第一抗凝劑的第二抗凝劑混合。可選地，所述不超過300微升的樣本之各部分處於其各自樣本器皿 中。可選地，可執行兩項或更多項測試，其中所述不超過300微升的樣本全部於單個器皿中加以運送，並包含單種抗凝劑。可選地，運用總體積不超過300微升的為所有測試而採自對象的血液，可執行清單中至少任意三項測試。可選地，運用總體積不超過300微升的為所有測試而採自對象的血液，可執行清單中至少任意五項測試。可選地，運用總體積不超過300微升的為所有測試而採自對象的血液，可執行清單中至少任意七項測試。可選地，運用總體積不超過300微升的為所有測試而採自對象的血液，可執行清單中至少任意十項測試。可選地，運用總體積不超過300微升的為所有測試而採自對象的血液，可執行清單中至少任意十五項測試。可選地，運用總體積不超過300微升的為所有測試而採自對象的血液，可執行清單中至少任意二十項測試。對於上述任意一種，於至少一些實施例中，至少一部分具有第一抗凝劑，第二部分具有不同於第一抗凝劑的第二抗凝劑。 Referring now to FIGS. 49 to 51, it should be understood that at least any two tests in the list (FIGS. 49 to 51) can be performed using samples collected or delivered according to the system or method provided herein. For example, at least two tests in the list may be performed on a body fluid sample taken from a subject, wherein the total volume of the body fluid sample used to perform the test does not exceed 300 microliters, and the total volume of the body fluid sample taken from the subject is Liquid form has 400 μl or more It is transported in a sample vessel with a small internal volume. In another example, at least two tests in the list may be performed on a body fluid sample collected from the subject, wherein the total volume of the body fluid sample used to perform the test does not exceed 300 microliters, and the total volume of the body fluid sample collected from the subject The volume is transported in a liquid form in the first sample vessel and the second sample vessel, each vessel having an internal volume of 200 microliters or less, the first sample vessel contains a body fluid sample mixed with the first anticoagulant, and The second sample vessel contains a sample of body fluid mixed with a second anticoagulant. In the embodiment, the total volume is not greater than or equal to 5ml, 4ml, 3ml, 2ml, 1.5ml, 1ml, 750μl, 500μl, 400μl, 300μl, 200μl, 150μl, 100μl, 75μl, 50μl, 40μl, 30μl, 20μl, 10μl , 5μl or 1μl of body fluid samples taken from the subject, at least 2,3,4,5,6,7,8,9,10,11,12,13,14,15 in the executable list (Figures 49 to 51) , 20, 25, 30, 35, 40, 50 or 60 tests. The total volume of the body fluid sample can be stored in a single sample vessel or transported from the collection site to an analysis or processing location, or it can be placed separately at 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25 or more sample vessels. When the total volume of a body fluid sample taken from a single subject is divided into two or more sample vessels, the sample portion in some or each of the sample vessels may contain a different anticoagulant or other additives. In one example, a total volume of no more than 300 microliters of a body fluid sample taken from a subject may be used to perform two or more tests, wherein at least a portion of the sample of no more than 300 microliters is linked The second part of the sample not exceeding 300 microliters is mixed with a second anticoagulant different from the first anticoagulant. Optionally, each part of the sample not exceeding 300 μl is in its respective sample vessel in. Alternatively, two or more tests may be performed, wherein the sample not exceeding 300 microliters are all transported in a single vessel and contain a single anticoagulant. Optionally, at least any three tests in the list can be performed using blood collected from the subject for all tests with a total volume not exceeding 300 microliters. Optionally, at least any five tests in the list can be performed using blood collected from the subject for all tests with a total volume not exceeding 300 microliters. Alternatively, at least any seven tests in the list can be performed using blood collected from the subject for all tests with a total volume not exceeding 300 microliters. Optionally, using a total volume of not more than 300 microliters of blood collected from the subject for all tests, at least any ten tests in the list can be performed. Optionally, using a total volume of not more than 300 microliters of blood collected from the subject for all tests, at least any fifteen tests in the list can be performed. Optionally, using a total volume of not more than 300 microliters of blood collected from the subject for all tests, at least any twenty tests in the list can be performed. For any of the above, in at least some embodiments, at least a portion has a first anticoagulant and a second portion has a second anticoagulant different from the first anticoagulant.

實例 Examples

以下提供之實例僅用於圖示目的，並不旨在以任何方式限定本揭示。 The examples provided below are for illustration purposes only and are not intended to limit the present disclosure in any way.

第一實例First instance

自對象採集全血樣本。對該全血樣本於器皿中進行離心分離，以便將全血分離為細胞團及血漿上清液。將經離心處理之器皿移至經氬氣吹驅手套箱中。從經離心處理之器皿中吸取血漿，隨後將其分開置於5個單獨的如 本文所提供之樣本器皿中，其中各樣本器皿具有不大於100微升之內部體積，其中不超過95微升的血漿被置於各樣本器皿中，且其中各樣本器皿具有相同尺寸並接收相同體積之血漿。所述器皿各自配有可移除丁基合成橡膠帽。所述5個樣本器皿貼有“0小時”、“1小時”、“2小時”、“8小時”及“24小時”的標籤。於各樣本器皿所示時間段，分析各器皿中樣本的重碳酸鹽。分析結果如表1所列。 Collect a whole blood sample from the subject. The whole blood sample is centrifuged in a vessel to separate the whole blood into cell mass and plasma supernatant. Move the centrifuged vessel into the glove box with argon blowing. Aspirate the plasma from the centrifuged vessel, and then separate it into 5 separate The sample vessels provided herein, wherein each sample vessel has an internal volume not greater than 100 microliters, wherein no more than 95 microliters of plasma is placed in each sample vessel, and wherein each sample vessel has the same size and receives the same volume Of plasma. The vessels are each equipped with a removable butyl synthetic rubber cap. The five sample vessels are labeled with "0 hours", "1 hour", "2 hours", "8 hours" and "24 hours". The samples in each vessel were analyzed for bicarbonate during the time period indicated in each vessel. The analysis results are listed in Table 1.

如表1所示，樣本中的重碳酸鹽於本文所提供的樣本器皿中保持穩定至少24小時。 As shown in Table 1, the bicarbonate in the sample remained stable for at least 24 hours in the sample vessel provided herein.

第二實例Second instance

自對象採集全血樣本。將該全血樣本與EDTA混合。80微升含EDTA之血液被分置於10個如本文所提供之樣本器皿中，其中各樣本器皿之內部體積不大於100微升，且皆具有相同尺寸。所述樣本器皿之分析標籤如下：實時：第1、2、3、4、5及7天；預離心分離：第1、2、4及7天。各“預離心分離”器皿於樣本被分置於器皿時被離心，以生成血漿及細胞團。各“實時”器皿於其各自日 期被離心，以生成血漿及細胞團。當樣本被分置於各樣本器皿後，為器皿套上帽子。於各器皿之日期，從器皿中移除血漿，分析其血尿素氮(BUN)。圖48繪示BUN分析結果。如圖所示，對於全血及血漿樣本中，本文所提供的樣本器皿中樣本之BUN皆保持穩定至少7天。 Collect a whole blood sample from the subject. The whole blood sample was mixed with EDTA. 80 microliters of EDTA-containing blood is divided into 10 sample vessels as provided herein, wherein the internal volume of each sample vessel is not greater than 100 microliters, and all have the same size. The analysis labels of the sample vessels are as follows: real-time: days 1, 2, 3, 4, 5, and 7; pre-centrifugation: days 1, 2, 4, and 7; Each "pre-centrifuge" vessel is centrifuged when the sample is placed in the vessel to generate plasma and cell pellets. Each "real-time" instrument on its own day The phase is centrifuged to generate plasma and cell mass. After the sample is divided into each sample vessel, put a cap on the vessel. On the date of each vessel, plasma was removed from the vessel and analyzed for blood urea nitrogen (BUN). Figure 48 shows the BUN analysis results. As shown in the figure, for the whole blood and plasma samples, the BUN of the samples in the sample vessel provided herein remains stable for at least 7 days.

於實施例中，用於本文所提供系統、裝置或方法之體液樣本可經稀釋。於實施例中，體液樣本可於其自第一位置運送至第二位置前經稀釋。於實施例中，體液樣本可於其自第一位置運送至第二位置後經稀釋。於實施例中，體液樣本可於其自第一位置運送至第二位置後，並於其被用於執行實驗室測試之一步或多步步驟前經稀釋。舉例而言，初始體液樣本可被稀釋至少2、3、4、5、6、7、8、9、10、15、20、50、100、200、300、400、500、1000、5,000、10,000、50,000或100,000倍。如本文用法，“n倍”稀釋係指對初始樣本之多倍稀釋。例如，初始樣本經5倍稀釋後，係包含有其初始濃度1/5的初始樣本；類似地，初始樣本經500倍稀釋後，係包含有其初始濃度1/500的初始樣本。體液樣本可被分隔成任意數目之部分，不同部分可經不同程度之稀釋，由此初始液體樣本可經處理，生成多個稀釋樣本，其各自具有不同稀釋程度。舉例而言，初始液體樣本因此可被分為5部分，其中一部分稀釋8倍，另一部分稀釋12倍，另一部分稀釋3倍，另一部分稀釋400倍，還有一部分稀釋2000倍。可逐步或於單個步驟中完成樣本稀釋。對於單步稀釋，選定之 量之樣本可與選定之量之稀釋劑混合，以便實現對樣本之所需稀釋。對於逐步稀釋，可執行對樣本之兩次或更多次依次分別稀釋，，以便實現對樣本之所需稀釋。舉例而言，可執行對樣本的第一次稀釋，該第一次稀釋之一部分可被用作第二次稀釋之輸入材料，以獲得達到選定稀釋程度的樣本。 In embodiments, the body fluid samples used in the systems, devices or methods provided herein can be diluted. In an embodiment, the body fluid sample may be diluted before it is transported from the first location to the second location. In an embodiment, the body fluid sample can be diluted after it is transported from the first location to the second location. In an embodiment, the body fluid sample can be diluted after it is transported from the first location to the second location and before it is used to perform one or more steps of the laboratory test. For example, the initial body fluid sample can be diluted by at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 , 50,000 or 100,000 times. As used herein, "n-fold" dilution refers to multiple dilutions of the original sample. For example, after the initial sample is diluted by 5 times, it contains the initial sample of 1/5 of its initial concentration; similarly, after the initial sample is diluted by 500 times, it contains the initial sample of 1/500 of its initial concentration. The body fluid sample can be divided into any number of parts, and different parts can be diluted to different degrees, so that the initial liquid sample can be processed to generate multiple diluted samples, each of which has a different degree of dilution. For example, the initial liquid sample can therefore be divided into 5 parts, one part is diluted 8 times, the other part is diluted 12 times, the other part is diluted 3 times, the other part is diluted 400 times, and the other part is diluted 2000 times. Sample dilution can be done step by step or in a single step. For single-step dilution, select The amount of sample can be mixed with the selected amount of diluent in order to achieve the desired dilution of the sample. For gradual dilution, two or more successive dilutions of the sample can be performed in order to achieve the desired dilution of the sample. For example, a first dilution of the sample can be performed, and a portion of the first dilution can be used as input material for the second dilution to obtain a sample at a selected dilution level.

對於本文所述稀釋，“初始樣本”係指特定稀釋過程開始時所用樣本。由此，儘管“初始樣本”可為直接採自對象之樣本(例如全血)，其亦可包括用作特定稀釋過程開始材料之任意其他樣本(例如，已經處理或先前於另一稀釋程序中經稀釋之樣本)。 For the dilution described herein, "initial sample" refers to the sample used at the beginning of a particular dilution process. Thus, although the "initial sample" may be a sample taken directly from the subject (such as whole blood), it may also include any other samples used as starting materials for a particular dilution process (eg, already processed or previously in another dilution procedure) Diluted sample).

於一些實施例中，可如下執行對樣本之逐步稀釋。選定之量(例如體積)之初始樣本可與選定之量之稀釋劑混合，以生成第一稀釋樣本。該第一稀釋樣本(及任意其後稀釋樣本)將具有：i)樣本稀釋因子(例如，該第一稀釋樣本中，初始樣本被稀釋值)及ii)初始之量(例如，將選定之量之初始樣本與選定之量之稀釋劑混合後，所存在的該第一稀釋樣本總量)。舉例而言，10微升初始樣本可與40微升稀釋劑混合，生成具有5倍樣本稀釋因子(與初始樣本相比較)及50微升之初量之第一稀釋樣本。下一步，選定之量之第一稀釋樣本可與選定之量之稀釋劑混合，以生成第二稀釋樣本。舉例而言，5微升第一稀釋樣本可與95微升稀釋劑混合，生成具有100倍樣本稀釋因子(與初始樣本相比較)及100微升之初量之第二稀釋樣 本。對於以上各稀釋步驟，初始樣本、稀釋樣本及稀釋劑可儲存或混合於液體隔離器皿中。可按前述方式以需要次數繼續其後稀釋，以達到選定樣本稀釋程度/稀釋因子。於實施例中，舉例而言，可按2013年2月18日提交之美國專利申請案第13/769,820號或本文他處經引用而合併之任意其他文件中所述稀釋樣本。 In some embodiments, the gradual dilution of the sample can be performed as follows. A selected amount (eg, volume) of the initial sample can be mixed with the selected amount of diluent to generate a first diluted sample. The first diluted sample (and any subsequent diluted samples) will have: i) the sample dilution factor (for example, in this first diluted sample, the initial sample is diluted) and ii) the initial amount (for example, the amount to be selected After the initial sample is mixed with the selected amount of diluent, the total amount of the first diluted sample present). For example, an initial sample of 10 microliters can be mixed with 40 microliters of diluent to generate a first diluted sample with a 5 times sample dilution factor (compared to the initial sample) and an initial volume of 50 microliters. Next, the selected amount of the first diluted sample can be mixed with the selected amount of diluent to generate a second diluted sample. For example, 5 μl of the first dilution sample can be mixed with 95 μl of diluent to generate a second dilution sample with a 100-fold sample dilution factor (compared to the initial sample) and an initial volume of 100 μl this. For each of the above dilution steps, the initial sample, diluted sample and diluent can be stored or mixed in a liquid isolation vessel. The subsequent dilution can be continued as many times as necessary to achieve the selected sample dilution / dilution factor. In the examples, for example, the sample may be diluted as described in US Patent Application No. 13 / 769,820 filed on February 18, 2013 or any other document incorporated by reference elsewhere herein.

如本文用法，作為或可被用作“稀釋劑”之試劑為，例如，有益於增加樣本或樣本部分的體積，或有益於液體製劑製備，諸如經冷凍乾燥後復原的製劑，或有益於因任意其他原因添加至樣本、溶液或材料中。於實施例中，稀釋劑可經緩衝(例如，pH值接近7或7.4或其他所需pH值)，且可為醫藥上可接受(對人類服用安全且無毒)。稀釋劑通常不與樣本中分析物反應或結合。水可作為稀釋劑，鹽水溶液、緩衝液、含有介面活性劑之溶液或任意其他溶液亦可作為稀釋劑。示例性稀釋劑包括無菌水、加抑菌劑注射用水(BWFI)、pH緩衝液(例如，磷酸鹽緩衝鹽水)、無菌鹽水、林格注射液或葡萄糖液。於實施例中，稀釋劑可包括鹽水溶液或緩衝液。 As used herein, a reagent that is or can be used as a "diluent" is, for example, beneficial to increase the volume of a sample or sample portion, or beneficial to the preparation of a liquid formulation, such as a formulation that is reconstituted after freeze-drying, or beneficial Add to sample, solution or material for any other reason. In an embodiment, the diluent may be buffered (eg, with a pH value close to 7 or 7.4 or other desired pH value), and may be pharmaceutically acceptable (safe and non-toxic for human consumption). The diluent usually does not react or bind to the analyte in the sample. Water can be used as a diluent, and saline solution, buffer, surfactant-containing solution or any other solution can also be used as a diluent. Exemplary diluents include sterile water, bacteriostatic water for injection (BWFI), pH buffer (eg, phosphate buffered saline), sterile saline, Ringer's injection, or glucose solution. In an embodiment, the diluent may include saline solution or buffer.

於實施例中，舉例而言，依照本文所提供系統或方法採自對象、經處理或運送之體液樣本或其部分可分開為至少2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、50、100、200、300、400、500、1000、5,000、10,000或更多不同部分。有關本文所提供將一個樣本分開為多個部分的說明，“初始樣本”係指特定分開過 程開始時所用樣本。由此，舉例而言，儘管“初始樣本”可為直接採自對象之樣本(例如全血)，其亦可包括用作特定樣本分開過程開始材料之任意其他樣本(例如，已經處理或先前於另一樣本分開程序中經分開之樣本)。於實施例中，可對“初始樣本”執行樣本分開及稀釋兩個步驟；於此情形中，“初始樣本”係指樣本稀釋/樣本分開組合過程所用開始材料。當樣本被分開為不同部分時，該等不同部分可包含不同量之初始樣本。舉例而言，如果體積為100微升之初始樣本被分為5部分，一部分可包含50微升初始樣本，另一部分可包含25微升初始樣本，另一部分可包含15微升初始樣本，另一部分可包含8微升初始樣本，且最後部分可包含2微升初始樣本。同樣地，當樣本既經稀釋，又經分開成為不同部分時，該等不同部分相對於初始樣本可具有不同稀釋程度。舉例而言，如果初始樣本被分為三個部分，一個部分相對於初始樣本可被稀釋5倍，另一部分相對於初始樣本可被稀釋20倍，而第三部分相對於初始樣本可被稀釋200倍。 In an embodiment, for example, a body fluid sample taken from a subject, processed or transported according to the system or method provided herein or a portion thereof can be divided into at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 or more different parts. For the instructions provided in this article to divide a sample into multiple parts, "initial sample" refers to a specific separation The sample used at the beginning of the process. Thus, for example, although the "initial sample" may be a sample taken directly from the subject (eg, whole blood), it may also include any other sample used as the starting material for a particular sample separation process (eg, has been processed or previously (Separated samples in another sample separation procedure). In an embodiment, two steps of sample separation and dilution can be performed on the "initial sample"; in this case, "initial sample" refers to the starting material used in the sample dilution / sample separation process. When the sample is divided into different parts, these different parts may contain different amounts of initial samples. For example, if an initial sample with a volume of 100 microliters is divided into 5 parts, one part may contain 50 microliters of the initial sample, another part may contain 25 microliters of the initial sample, another part may contain 15 microliters of the initial sample, and another It may contain an initial sample of 8 microliters, and the last part may contain an initial sample of 2 microliters. Similarly, when the sample is both diluted and separated into different parts, these different parts may have different degrees of dilution relative to the original sample. For example, if the initial sample is divided into three parts, one part can be diluted 5 times relative to the initial sample, the other part can be diluted 20 times relative to the initial sample, and the third part can be diluted 200 relative to the initial sample. Times.

由此，於一個實例中，體液樣本可於第一位置(例如，樣本採集地點)採自對象。首次採自對象之此體液樣本可被視為“初始樣本”。舉例而言，此“初始樣本”可為採自對象之小量(例如，少於400、300、200或100微升)全血。從對象採集此“初始樣本”過後不久或與其同時，此“初始樣本”可被分為至少第一部分和第二部分，其中第一部分被傳遞至第一器皿，第二部分被傳遞 至第二器皿。於實施例中，第一器皿可包含第一抗凝劑(例如，EDTA)及第二器皿可包含第二抗凝劑(例如肝磷脂)。可依照本文所提供系統或方法，將所述第一及第二器皿自第一位置運送至第二位置。於實施例中，可在第二位置對所述器皿之一或兩者中的樣本或其部分採取進一步處理或分析步驟。 Thus, in one example, the body fluid sample may be taken from the subject at the first location (eg, the sample collection location). This body fluid sample taken from the subject for the first time can be regarded as an "initial sample". For example, this "initial sample" may be a small amount (eg, less than 400, 300, 200, or 100 microliters) of whole blood taken from the subject. Shortly after or at the same time as the "initial sample" is collected from the subject, the "initial sample" can be divided into at least a first part and a second part, where the first part is transferred to the first vessel and the second part is transferred To the second vessel. In an embodiment, the first vessel may include a first anticoagulant (eg, EDTA) and the second vessel may include a second anticoagulant (eg, heparin). The first and second vessels can be transported from the first location to the second location according to the systems or methods provided herein. In an embodiment, further processing or analysis steps may be taken on the sample or part of one or both of the vessels at the second location.

於另一實例中，體液樣本可依照本文所提供系統或方法於器皿中從第一位置被運送至第二位置。所述器皿中體液樣本可為採自對象之樣本的全部或其部分。於第二位置，所述器皿中至少一些體液樣本可從器皿中移除，並被用於樣本分開和/或稀釋程序。從器皿中移除並被用於樣本分開和/或稀釋程序之樣本可被視為“初始樣本”。舉例而言，該初始樣本可為全血、血漿、血清、唾液或尿樣，並可構成於器皿中運送之樣本的全部或其部分。該初始樣本可被分隔為任意數目之部分；所述不同部分相對於初始樣本可經不同程度之稀釋。舉例而言，自經運送器皿中移除之初始樣本其體積可小於或等於400、300、250、200、150、100、90、80、70、60、50、40、30、25、20、15、10、9、8、7、6、5、4、3、2或1微升。自經運送器皿中移除之該初始樣本隨後可被分為至少2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、50、100、200、300、400、500、1000、5,000、10,000或更多不同部分。於實施例中，該等不同部分相對於初始樣本可經不同程度之稀釋。舉例而言，該 等不同部分相對於初始樣本可經至少2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、50、100、200、300、400、500、1000或5,000種不同程度之稀釋，其前提為，具有不同程度稀釋之部分數目不超過自初始樣本準備之部分總數目。該等不同部分相對於初始樣本可經過任意類型的稀釋，舉例而言，包括無稀釋、至少2倍稀釋、至少3倍稀釋、至少5倍稀釋、至少10倍稀釋、至少20倍稀釋、至少50倍稀釋、至少100倍稀釋、至少500倍稀釋、至少1000倍稀釋、至少5000倍稀釋、至少10000倍稀釋、至少50000倍稀釋或至少100000倍稀釋。於實施例中，初始樣本之一個或多個不同部分可被用於一種實驗室測試。於實施例中，初始樣本之一個部分可被用於一種實驗室測試。被用於一種實驗室測試之初始樣本一部分可為經稀釋樣本。 In another example, the body fluid sample can be transported from the first location to the second location in the vessel in accordance with the systems or methods provided herein. The body fluid sample in the vessel may be all or part of the sample taken from the subject. In the second position, at least some of the body fluid samples in the vessel can be removed from the vessel and used for sample separation and / or dilution procedures. Samples removed from the vessel and used in the sample separation and / or dilution procedure can be considered as "initial samples". For example, the initial sample may be a whole blood, plasma, serum, saliva, or urine sample, and may constitute all or part of the sample transported in the vessel. The initial sample can be divided into any number of parts; the different parts can be diluted to varying degrees relative to the initial sample. For example, the volume of the initial sample removed from the transport vessel may be less than or equal to 400, 300, 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 microliter. The initial sample removed from the transport vessel can then be divided into at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100 , 200, 300, 400, 500, 1000, 5,000, 10,000 or more different parts. In an embodiment, these different parts can be diluted to different degrees relative to the initial sample. For example, the The different parts can pass through at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000 or 5,000 different degrees of dilution, provided that the number of parts with different degrees of dilution does not exceed the total number of parts prepared from the initial sample. These different parts can be subjected to any type of dilution relative to the initial sample, including, for example, no dilution, at least 2-fold dilution, at least 3-fold dilution, at least 5-fold dilution, at least 10-fold dilution, at least 20-fold dilution, at least 50 Fold dilution, at least 100 fold dilution, at least 500 fold dilution, at least 1000 fold dilution, at least 5,000 fold dilution, at least 10,000 fold dilution, at least 50,000 fold dilution, or at least 100,000 fold dilution. In an embodiment, one or more different parts of the initial sample can be used for a laboratory test. In an embodiment, a portion of the initial sample can be used for a laboratory test. A portion of the initial sample used in a laboratory test may be a diluted sample.

於實施例中，初始樣本可被分為至少2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、50、100、200、300、400、500、1000、5,000、10,000或更多不同部分，且該等不同部分被用於完成至少2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、50、100、200、300、400、500、1000、5,000、10,000項不同實驗室測試。於一些實施例中，係準備至少與對樣本部分所完成之實驗室測試同等數目的樣本部分(例如，為對初始樣本完成10項實驗室測試，該初始樣本可被分為至少10個部分，每個測試使用至少1個部分)。於特定其他 實施例中，可對單個樣本完成多於一項實驗室測試。舉例而言，於實施例中，可測量樣本的一種光學特性(例如，血樣中的細胞計數)，隨後，同一樣本可被用於分析血液中的一種分析物。由此，於一些實施例中，對初始樣本所完成實驗室測試的項數多於自同一初始樣本準備的部分數目(例如，可對僅被分為8部分的初始樣本完成10項實驗室測試)。 In an embodiment, the initial sample may be divided into at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 or more different parts, and these different parts are used to complete at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30 , 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 different laboratory tests. In some embodiments, at least the same number of sample parts as the laboratory tests performed on the sample parts are prepared (eg, to complete 10 laboratory tests on the initial sample, the initial sample can be divided into at least 10 parts, Use at least 1 part for each test). Specific In embodiments, more than one laboratory test can be completed on a single sample. For example, in an embodiment, an optical characteristic of a sample (eg, cell count in a blood sample) can be measured, and then the same sample can be used to analyze an analyte in blood. Thus, in some embodiments, the number of laboratory tests completed on the initial sample is greater than the number of parts prepared from the same initial sample (for example, 10 laboratory tests can be completed on an initial sample divided into only 8 parts) ).

當初始樣本被分為多個部分，且該多個部分被用於完成兩項或更多項實驗室測試時，所述實驗室測試可為同類型實驗室測試，或可為不同類型實驗室測試。舉例而言，如果初始樣本被分為10個部分，且該10個部分各自被用於一項實驗室測試，則各部分所完成之實驗室測試可為一項基於抗體的測試。於另一實例中，如果初始樣本被分為5個部分，且該5個部分各自被用於一項實驗室測試，則各部分所完成之實驗室測試可為一項基於核酸擴增的測試。 When the initial sample is divided into multiple parts, and the multiple parts are used to complete two or more laboratory tests, the laboratory test may be the same type of laboratory test, or may be a different type of laboratory test test. For example, if the initial sample is divided into 10 parts and each of the 10 parts is used for a laboratory test, the laboratory test completed by each part may be an antibody-based test. In another example, if the initial sample is divided into 5 parts and each of the 5 parts is used for a laboratory test, the laboratory test completed by each part may be a nucleic acid amplification-based test .

於其他情形中，當初始樣本被分為多個部分，且該多個部分被用於完成兩項或更多項實驗室測試時，所述實驗室測試中至少兩項可為不同類型實驗室測試。舉例而言，如果初始樣本被分為5個部分，且該5個部分各自被用於一項實驗室測試，其中2個部分可被用於完成一項基於抗體的測試(例如ELISA)，另3個部分可被用於完成一項基於核酸擴增的測試。 In other cases, when the initial sample is divided into multiple parts and the multiple parts are used to complete two or more laboratory tests, at least two of the laboratory tests may be different types of laboratories test. For example, if the initial sample is divided into 5 parts, and each of the 5 parts is used for a laboratory test, 2 of the parts can be used to complete an antibody-based test (such as ELISA), and Three sections can be used to complete a nucleic acid amplification-based test.

於實施例中，初始樣本可為採自對象之全血樣本。該初始樣本可採自對象手指。該初始樣本體積可為不大於400、300、200、150、100、90、80、70、60、50、40、30、20或10微升。該初始樣本可被分為多個部分。可於依照本文所提供系統或方法將樣本自第一位置運送至第二位置之前、之後或其前後組合，將樣本分為多個部分。於實施例中，該初始樣本可被分為至少2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、50、100、200、300、400、500、1000、5,000、10,000或更多個不同部分，且該等不同部分可被用於完成至少2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、50、100、200、300、400、500、1000、5,000、10,000項不同實驗室測試。該初始樣本之不同部分可具有經稀釋初始樣本。於實施例中，每項實驗室測試可使用不超過10、9、8、7、6、5、4、3、2、1、0.9、0.8、0.7、0.6、0.5、0.4、0.3、0.2、0.1、0.05或0.01微升的初始樣本。 In an embodiment, the initial sample may be a whole blood sample taken from the subject. This initial sample can be taken from the subject's finger. The initial sample volume may be no greater than 400, 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 20 or 10 microliters. The initial sample can be divided into multiple parts. The sample can be divided into multiple parts before, after, or a combination of transporting the sample from the first location to the second location according to the system or method provided herein. In an embodiment, the initial sample can be divided into at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300 , 400, 500, 1000, 5,000, 10,000 or more different parts, and these different parts can be used to complete at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 different laboratory tests. Different parts of the initial sample may have a diluted initial sample. In the embodiments, each laboratory test can use no more than 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1, 0.05 or 0.01 microliter initial sample.

於實施例中，初始樣本可為從採自對象之全血樣本中獲得的血漿或血清。該全血可採自對象手指。從其獲得血漿或血清的該全血樣本體積可為不大於400、300、200、150、100、90、80、70、60、50、40、30、20或10微升。該血漿或血清初始樣本體積可為不大於300、200、150、100、90、80、70、60、50、40、30、 20或10微升。該初始樣本可被分為多個部分。可於依照本文所提供系統或方法將樣本自第一位置運送至第二位置之前、之後或其前後組合，將樣本分為多個部分。於實施例中，該初始樣本可被分為至少2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、50、100、200、300、400、500、1000、5,000、10,000或更多個不同部分，且該等不同部分可被用於完成至少2、3、4、5、6、7、8、9、10、15、20、25、30、35、40、50、100、200、300、400、500、1000、5,000、10,000項不同實驗室測試。該初始樣本之不同部分可具有經稀釋初始樣本。於實施例中，每項實驗室測試可使用不超過10、9、8、7、6、5、4、3、2、1、0.9、0.8、0.7、0.6、0.5、0.4、0.3、0.2、0.1、0.05或0.01微升的初始樣本。 In an embodiment, the initial sample may be plasma or serum obtained from a whole blood sample taken from the subject. The whole blood can be collected from the subject's finger. The volume of the whole blood sample from which plasma or serum is obtained may be no greater than 400, 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 20 or 10 microliters. The initial sample volume of the plasma or serum may be no greater than 300, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30, 20 or 10 microliters. The initial sample can be divided into multiple parts. The sample can be divided into multiple parts before, after, or a combination of transporting the sample from the first location to the second location according to the system or method provided herein. In an embodiment, the initial sample can be divided into at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300 , 400, 500, 1000, 5,000, 10,000 or more different parts, and these different parts can be used to complete at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 50, 100, 200, 300, 400, 500, 1000, 5,000, 10,000 different laboratory tests. Different parts of the initial sample may have a diluted initial sample. In the embodiments, each laboratory test can use no more than 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1, 0.05 or 0.01 microliter initial sample.

依照本文所提供系統或方法所運送之體液樣本或其部分可被用於各種類型實驗室測試中，諸如免疫測定技術、核酸擴增分析、一般化學分析或細胞分析。於實施例中，依照本文所提供系統或方法所運送之體液樣本或其部分可被用於本文所述任意類型分析或實驗室測試中，舉例而言，如2013年2月18日提交之美國專利申請案第13/769,820號或本文他處經引用而合併之任意其他文件中所述。 Body fluid samples or portions thereof transported in accordance with the systems or methods provided herein can be used in various types of laboratory tests, such as immunoassay techniques, nucleic acid amplification analysis, general chemical analysis, or cell analysis. In the embodiments, the body fluid samples or parts thereof transported according to the system or method provided herein can be used in any type of analysis or laboratory test described herein, for example, as submitted in the United States on February 18, 2013 Patent Application No. 13 / 769,820 or any other document incorporated by reference elsewhere in this document.

於一些實施例中，依照本文所提供系統或方法所運送之體液樣本或其部分可被用於免疫測定技術。如本文用法，“免疫測定”係指採用與某種分析物有親合性之 抗體探測該分析物的任意分析。舉例而言，免疫測定可包括酵素連結免疫吸附(ELISA)分析。本文所用術語“抗體”係指免疫球蛋白分子及免疫球蛋白分子之免疫活性部分，即含與抗原結合單位(“Abu”或複數形式之“Abus”)的分子，該單位特異性地抗原結合(“發生免疫反應”)。就結構而言，最簡單之自然存在抗體(例如IgG)含有四條多肽鏈、兩條重(H)鏈及兩條輕(L)鏈，彼此籍由雙硫鍵結合。所述免疫球蛋白代表很大的分子家族，其包括數種分子類型，諸如IgD、IgG、IgA、IgM及IgE。舉例而言，術語“免疫球蛋白分子”係包括雜交抗體或經改變抗體，及其片段。與抗原結合單位可基於其分子結構，被廣義地分為“單鏈”(“Sc”)及“非單鏈”(“Nsc”)類型。 In some embodiments, body fluid samples or portions thereof transported in accordance with the systems or methods provided herein can be used in immunoassay techniques. As used herein, "immunoassay" refers to the use of an affinity for an analyte The antibody detects any analysis of the analyte. For example, immunoassays can include enzyme-linked immunosorbent (ELISA) analysis. The term "antibody" as used herein refers to immunoglobulin molecules and immunologically active portions of immunoglobulin molecules, that is, molecules containing an antigen binding unit ("Abu" or plural "Abus") that specifically binds antigen ("An immune reaction occurs"). In terms of structure, the simplest naturally-occurring antibody (eg, IgG) contains four polypeptide chains, two heavy (H) chains, and two light (L) chains, which are bound to each other by disulfide bonds. The immunoglobulins represent a large family of molecules, including several molecular types, such as IgD, IgG, IgA, IgM, and IgE. For example, the term "immunoglobulin molecule" includes hybrid antibodies or modified antibodies, and fragments thereof. Antigen-binding units can be broadly divided into "single chain" ("Sc") and "non-single chain" ("Nsc") types based on their molecular structure.

術語“抗體”及“與抗原結合單位”亦涵蓋人類、非人類(源自脊椎動物或無脊椎動物)、混種性或人源化免疫球蛋白分子及其片段。為說明混種性及人源化抗體概念，請參閱Clark等人，2000及其引用文獻(Clark,(2000)，Immunol.Today，21：397-402)。於實施例中，本文所用“免疫分析”亦可包括如此的分析，即其中欲量測之分析物為抗體，且探測該抗體目的為抗體具有親合性之分子(例如抗體之目標分子)。 The terms "antibody" and "antigen-binding unit" also encompass human, non-human (derived from vertebrates or invertebrates), hybrid or humanized immunoglobulin molecules and fragments thereof. To illustrate the concept of hybridity and humanized antibodies, please refer to Clark et al., 2000 and references cited therein (Clark, (2000), Immunol. Today, 21: 397-402). In the embodiments, the "immunoassay" used herein may also include an analysis in which the analyte to be measured is an antibody, and the purpose of detecting the antibody is a molecule with which the antibody has affinity (eg, a target molecule of the antibody).

於一些實施例中，依照本文所提供系統或方法所運送之體液樣本或其部分可被用於核酸擴增分析。如本文用法，“核酸擴增分析”係指其中目標核酸複製數目可 得以增加之分析。核酸擴增分析可包括等溫及溫度變化擴增技術，且舉例而言，包括聚合酵素鏈鎖反應(PCR)及環式恆溫擴增法(LAMP)等技術。通常而言，核酸擴增分析係包括至少i)核酸聚合酵素，ii)可與目標核酸序列結合之引子，及iii)可籍由聚合酵素合併入合成核酸之自由核苷酸。可經由各種方式檢測目標核酸之擴增，諸如量測某一時間段中反應之熒光或濁度。 In some embodiments, body fluid samples or portions thereof transported in accordance with the systems or methods provided herein can be used for nucleic acid amplification analysis. As used herein, "nucleic acid amplification analysis" refers to a target nucleic acid where the number of copies can be Increased analysis. Nucleic acid amplification analysis may include isothermal and temperature change amplification technologies, and for example, include polymerase chain reaction (PCR) and loop constant temperature amplification (LAMP) technologies. In general, nucleic acid amplification analysis includes at least i) a nucleic acid polymerase, ii) a primer that can bind to a target nucleic acid sequence, and iii) a free nucleotide that can be incorporated into a synthetic nucleic acid by a polymerase. The amplification of the target nucleic acid can be detected in various ways, such as measuring the fluorescence or turbidity of the reaction in a certain period of time.

於一些實施例中，依照本文所提供系統或方法所運送之體液樣本或其部分可被用於一般化學分析。舉例而言，一般化學分析可包括以下各單項分析或其中任意組合：基礎代謝組合分析[葡萄糖、鈣、鈉(Na)、鉀(K)、氯(Cl)、CO2(二氧化碳、重碳酸鹽)、肌酸酐、血尿素氮(BUN)]、電解質組合分析[鈉(Na)、鉀(K)、氯(Cl)、CO2(二氧化碳、重碳酸鹽)]、14項化學組合/綜合代謝組合分析[葡萄糖、鈣、白蛋白、總蛋白質、鈉(Na)、鉀(K)、氯(Cl)、CO2(二氧化碳、重碳酸鹽)、肌酸酐、血尿素氮(BUN)、鹼性磷酸酶(ALP)、丙胺酸轉胺酶(ALT/GPT)、天門冬酸轉氨酶(AST/GOT)、總膽紅素]、脂質特徵/脂質組合分析[LDL膽固醇、HDL膽固醇、總膽固醇及三酸甘油酯]、肝組合/肝功能分析[鹼性磷酸酶(ALP)、丙胺酸轉胺酶(ALT/GPT)、天門冬酸轉氨酶(AST/GOT)、總膽紅素、白蛋白、總蛋白質、伽瑪麩胺醯轉移脢(GGT)、乳酸脫氫酶(LDH)、凝血酶原時間(PT)]、鹼性磷酸酶 (APase)、血色素、VLDL膽固醇、乙醇、脂肪酵素、pH、鋅紫質原、直接膽紅素、血型(ABO,RHD)、鉛、磷酸鹽、血球凝集抑制、鎂、鐵、鐵吸收、糞便潛血檢查等等。 In some embodiments, body fluid samples or portions thereof transported in accordance with the systems or methods provided herein can be used for general chemical analysis. For example, general chemical analysis may include the following individual analysis or any combination thereof: basal metabolic combination analysis [glucose, calcium, sodium (Na), potassium (K), chlorine (Cl), CO2 (carbon dioxide, bicarbonate) , Creatinine, blood urea nitrogen (BUN)], electrolyte combination analysis [sodium (Na), potassium (K), chlorine (Cl), CO2 (carbon dioxide, bicarbonate)], 14 chemical combinations / comprehensive metabolic combination analysis [Glucose, calcium, albumin, total protein, sodium (Na), potassium (K), chlorine (Cl), CO2 (carbon dioxide, bicarbonate), creatinine, blood urea nitrogen (BUN), alkaline phosphatase ( ALP), alanine aminotransferase (ALT / GPT), aspartate aminotransferase (AST / GOT), total bilirubin], lipid profile / lipid combination analysis [LDL cholesterol, HDL cholesterol, total cholesterol and triglycerides ], Liver combination / liver function analysis [alkaline phosphatase (ALP), alanine aminotransferase (ALT / GPT), aspartate aminotransferase (AST / GOT), total bilirubin, albumin, total protein, gamma Maltamine transferase (GGT), lactate dehydrogenase (LDH), prothrombin time (PT)], alkaline phosphatase (APase), hemoglobin, VLDL cholesterol, ethanol, lipase, pH, zinc-purpurin, direct bilirubin, blood type (ABO, RHD), lead, phosphate, hemagglutination inhibition, magnesium, iron, iron absorption, feces Occult blood test and so on.

於本文所提供之一般化學分析中，於一些實例中，樣本中分析物成分度籍由一步或多步分析步驟確定，其中涉及相關分析物與一種或多種試劑之反應，由此形成反應中可檢測之變化(例如，反應濁度變化、反應發光、反應顏色變化等)。於一些實例中，某一樣本之特性籍由一步或多步分析步驟確定，其中涉及相關樣本與一種或多種試劑之反應，由此形成反應中可檢測之變化(例如，反應濁度變化、反應發光、反應顏色變化等)。通常而言，如本文用法，“一般化學”分析不涉及核酸擴增、於顯微階段之細胞成像，或基於標記抗體/結合劑之運用對溶液中分析物成分度的確定，以確定溶液中分析物成分度。於一些實施例中，一般化學分析經由將所有試劑置於單個器皿中得以完成--即，為完成反應，所有必需試劑被添加至一個反應器皿中，且於分析過程中，不從反應或反應器皿中移除材料(例如，無清洗步驟；其係“混合並讀取”反應)。舉例而言，一般化學分析亦可為色度法分析、酵素分析、分光光度法分析、濁度法分析、凝集法分析、凝結法分析和/或其他類型之分析。可籍由於一個或多個選定波長處量測分析反應之光吸收度(例如，使用分光光度計)完成很多一般化學分析。於一些實施例中，可 籍由量測反應濁度(例如，使用分光光度計)完成一般化學分析。於一些實施例中，可籍由量測反應中產生之化學發光(例如，使用PMT、光電二極管或其他光學傳感器)完成一般化學分析。於一些實施例中，一般化學分析可籍由基於為同一或相關分析中一種或多種其他分析物而確定之實驗數值的計算完成。於一些實施例中，可籍由量測反應熒光(例如，使用包含或連接於i)具有特定波長(“激勵波長”)之光源；及ii)被配置為檢測於特定波長發射之光的傳感器(“發射波長”)的檢測單元)完成一般化學分析。於一些實施例中，可籍由量測反應中的凝集(例如，使用分光光度計量測反應濁度或籍由光學傳感器獲得反應圖像)完成一般化學分析。於一些實施例中，可籍由於一個或多個時間點對反應成像(例如，使用CCD或CMOS光學傳感器)，隨後進行圖像分析，由此完成一般化學分析。可選地，分析可包括凝血酶原時間、活化部分凝血活酶時間(APTT)，兩者任一皆可經由諸如但不限於濁度計法得以測量。於一些實施例中，可籍由量測反應黏度(例如，使用分光光度計，其中反應黏度增加改變反應的光學特性)完成一般化學分析。於一些實施例中，可籍由量測兩種非抗體試劑間複合體之形成(例如，一種金屬離子與一種發色團；此類反應可使用分光光度計或使用另一裝置經由色度法加以量測)完成一般化學分析。於一些實施例中，可籍由用於分析細胞抗原之非ELISA或基於細胞分析的方法(例如，用於血型之血球凝集，舉例而言， 其可籍由反應濁度得以量測)完成一般化學分析。於一些實施例中，可於電氣化學傳感器幫助下(例如，用於二氧化碳或氧氣)完成一般化學分析。亦可採用更多方法完成一般化學分析。 In the general chemical analysis provided herein, in some examples, the composition of the analyte in the sample is determined by one or more analysis steps, which involves the reaction of the relevant analyte with one or more reagents, thereby forming the reaction Detected changes (eg, reaction turbidity change, reaction luminescence, reaction color change, etc.). In some examples, the characteristics of a sample are determined by one or more analysis steps, which involve the reaction of the relevant sample with one or more reagents, thereby forming a detectable change in the reaction (eg, reaction turbidity change, reaction Glow, react to color changes, etc.). Generally speaking, as used herein, "general chemical" analysis does not involve nucleic acid amplification, cell imaging at the microscopic stage, or determination of the analyte composition in solution based on the use of labeled antibodies / binding agents to determine the solution Analyte composition. In some embodiments, general chemical analysis is accomplished by placing all reagents in a single vessel--that is, to complete the reaction, all necessary reagents are added to one reaction vessel, and during the analysis, no reaction or reaction is performed. The material is removed from the vessel (for example, no cleaning step; it is a "mix and read" reaction). For example, the general chemical analysis may also be colorimetric analysis, enzyme analysis, spectrophotometric analysis, turbidity analysis, agglutination analysis, coagulation analysis, and / or other types of analysis. Many general chemical analyses can be accomplished by measuring the absorbance of the analytical reaction at one or more selected wavelengths (for example, using a spectrophotometer). In some embodiments, The general chemical analysis is done by measuring the reaction turbidity (for example, using a spectrophotometer). In some embodiments, general chemical analysis can be performed by measuring the chemiluminescence generated in the reaction (eg, using PMT, photodiode, or other optical sensors). In some embodiments, general chemical analysis may be performed by calculation based on experimental values determined for one or more other analytes in the same or related analysis. In some embodiments, the reaction fluorescence can be measured (eg, using a light source containing or connected to i) having a specific wavelength ("excitation wavelength"); and ii) a sensor configured to detect light emitted at a specific wavelength ("Emission wavelength") detection unit) completes general chemical analysis. In some embodiments, general chemical analysis can be performed by measuring agglutination in the reaction (eg, measuring the turbidity of the reaction using spectrophotometry or obtaining the reaction image by an optical sensor). In some embodiments, the reaction can be imaged at one or more time points (eg, using a CCD or CMOS optical sensor), followed by image analysis, thereby completing the general chemical analysis. Alternatively, the analysis may include prothrombin time, activated partial thromboplastin time (APTT), either of which may be measured via methods such as, but not limited to, turbidimetry. In some embodiments, the general chemical analysis can be performed by measuring the reaction viscosity (for example, using a spectrophotometer where the reaction viscosity increases to change the optical characteristics of the reaction). In some embodiments, the formation of a complex between two non-antibody reagents can be measured (eg, a metal ion and a chromophore; such reactions can be performed using a spectrophotometer or using another device via colorimetry Measure) to complete the general chemical analysis. In some embodiments, non-ELISA or cell-based methods for analyzing cell antigens (eg, for hemagglutination of blood types, for example, It can be measured by reaction turbidity) to complete general chemical analysis. In some embodiments, general chemical analysis can be performed with the help of an electrochemical sensor (for example, for carbon dioxide or oxygen). More methods can also be used to complete general chemical analysis.

於一些實施例中，可運用分光光度計進行一般化學分析化驗。於一些實施例中，一般化學分析化驗可於分析結束(“終點”分析)或於分析過程中兩個或更多個時間點(“時間序”或“動力”分析)處進行。 In some embodiments, a spectrophotometer can be used for general chemical analysis and testing. In some embodiments, the general chemical analysis assay can be performed at the end of the analysis ("end point" analysis) or at two or more time points ("chronological" or "kinetic" analysis) during the analysis.

於一些實施例中，依照本文所提供系統或方法所運送之體液樣本或其部分可被用於細胞分析。通常而言，細胞分析被用於光學地、電氣地或聲學地測量單個細胞特徵。就本揭示而言，“細胞”可涵蓋總體而言與單個細胞具有相似尺寸之非細胞樣本，包括但不限於小囊(如脂質體)、小細胞群、病毒體、細菌、原生動物類、晶體、脂質和/或蛋白質聚合形成的個體，及約束於諸如微珠或微球等小顆粒上之物質。此類特徵包括但不限於尺寸；形狀；粒度；光散射式樣(或光性指示體)；細胞膜是否完整；內部細胞內容之濃度、形態及時空分佈，包括但不限於蛋白質內容、蛋白質改性、核酸內容、核酸改性、細胞器官內容、細胞核結構、細胞核內容、內部細胞結構、內部囊內容(包括pH)、鐵濃度及類固醇或藥物等其他小分子之存在；及細胞表面(細胞膜及細胞壁)標記，包括蛋白質、脂質、碳水化合物及其改造。籍由採用適當染料、染色或其他標記分子，該等標記分子為純粹形態、與其他 分子共軛或固定於或結合於奈米或微顆粒，細胞分析可被用於確定特定蛋白質、核酸、脂質、碳水化合物或其他分子之存在、數量和/或改造。舉例而言，細胞分析可籍由流式細胞術或籍由顯微術完成。流式細胞術通常採用移動液體介質，其依序將單個細胞傳遞至光學、電學或聲學檢測器。顯微術通常運用光學或聲學手段檢測靜止細胞，一般籍由記錄至少一張放大圖像。於實施例中，細胞分析可包括獲得樣本中一個或多個細胞的圖像。於實施例中，可於顯微鏡載片上或比色管中提供樣本，這可使樣本中細胞能夠以成像所需配置結構沈澱。舉例而言，可運用基於CCD或CMOS之攝影機獲取細胞圖像。 In some embodiments, body fluid samples or portions thereof transported in accordance with the systems or methods provided herein can be used for cell analysis. In general, cell analysis is used to optically, electrically, or acoustically measure individual cell characteristics. For the purposes of this disclosure, "cells" may encompass non-cellular samples that are generally similar in size to a single cell, including but not limited to small vesicles (such as liposomes), small cell populations, virions, bacteria, protozoa, Individuals formed by the polymerization of crystals, lipids, and / or proteins, and substances bound to small particles such as microbeads or microspheres. Such characteristics include but are not limited to size; shape; particle size; light scattering pattern (or optical indicator); whether the cell membrane is intact; the concentration, morphology and spatial and temporal distribution of internal cell contents, including but not limited to protein content, protein modification, Nucleic acid content, nucleic acid modification, cell organ content, cell nuclear structure, cell nuclear content, internal cell structure, internal capsule content (including pH), iron concentration and the presence of other small molecules such as steroids or drugs; and cell surface (cell membrane and cell wall) Markers, including proteins, lipids, carbohydrates and their modifications. By using appropriate dyes, stains, or other marker molecules, these marker molecules are in pure form, with other The molecules are conjugated or fixed to or bound to nanoparticles or microparticles, and cell analysis can be used to determine the presence, quantity, and / or modification of specific proteins, nucleic acids, lipids, carbohydrates, or other molecules. For example, cell analysis can be done by flow cytometry or by microscopy. Flow cytometry usually uses a moving liquid medium, which sequentially transfers individual cells to an optical, electrical, or acoustic detector. Microscopy usually uses optical or acoustic means to detect resting cells, usually by recording at least one enlarged image. In an embodiment, the cell analysis may include obtaining an image of one or more cells in the sample. In an embodiment, the sample may be provided on a microscope slide or in a colorimetric tube, which may enable cells in the sample to precipitate in a configuration required for imaging. For example, a CCD or CMOS-based camera can be used to obtain cell images.

於實施例中，為採用液體樣本之一部分完成分析/測試，所述液體樣本之一部分可被傳遞入分析單元進行至少一步所述分析/測試。分析單元可具有各種形狀係數，如吸量管管頭、試管或顯微鏡載片。舉例而言，可於分析單元中進行之分析步驟可包括樣本中分析物與分析物結合劑(例如抗體或核酸探針)結合、樣本中目標核酸於核酸擴增反應中被擴增、基於向樣本中加入一種或多種試劑進行的樣本凝集，或樣本採用適合於光學分析用配置結構(例如，細胞沈澱於顯微鏡載片表面，以便促進獲得一幅或多幅細胞圖像)。如本文用法，術語“分析”和“測試”可彼此交換使用，上下文中明確另行指定者除外。 In an embodiment, in order to complete the analysis / test using a part of the liquid sample, a part of the liquid sample may be transferred into the analysis unit for at least one step of the analysis / test. The analysis unit can have various shape factors, such as pipette tips, test tubes, or microscope slides. For example, the analysis step that can be performed in the analysis unit may include the binding of the analyte in the sample to the analyte binding agent (eg, antibody or nucleic acid probe), the target nucleic acid in the sample is amplified in the nucleic acid amplification reaction, based on Agglutination of the sample by adding one or more reagents to the sample, or the sample adopts a configuration suitable for optical analysis (for example, the cells are deposited on the surface of the microscope slide to facilitate the acquisition of one or more cell images). As used herein, the terms "analysis" and "test" are used interchangeably, unless the context clearly dictates otherwise.

現請參照圖52，其繪示體液樣本採集裝置又一實施例。圖52繪示位於對象上的一個體液樣本B籍由採集 裝置3710採集。如圖52所示，採集裝置3710可包括採集部分3712，諸如但不限於毛細管或其他採集結構。採集部分3712抽取其中液體，最終將其引導至裝置3710之內部空腔3714。當採集部分3712採集所需之量後，整個裝置3710可如圖52所示定位，使得重力可隨後將樣本抽取入空腔3714。當樣本B被全部移入空腔3714後，採集部分3712可被從裝置3710上移除。於一個實施例中，所述蓋及採集部分3712被移除，並被封閉蓋3718替代。於一個非限制性實例中，蓋3718其上可不設有任何開口。可選地，一些實施例可於蓋中設有隔膜或其他可關閉開口，其中可移除採集部分3712，而不需採用新的不同配置之部分替換所述蓋。 Refer now to FIG. 52, which illustrates another embodiment of a body fluid sample collection device. Figure 52 illustrates the collection of a body fluid sample B from the subject Device 3710 collects. As shown in FIG. 52, the collection device 3710 may include a collection portion 3712, such as but not limited to a capillary tube or other collection structure. The collecting part 3712 draws the liquid therein, and finally leads it to the internal cavity 3714 of the device 3710. After the collection portion 3712 collects the required amount, the entire device 3710 can be positioned as shown in FIG. 52 so that gravity can then draw the sample into the cavity 3714. After the sample B is completely moved into the cavity 3714, the collection portion 3712 can be removed from the device 3710. In one embodiment, the cover and collection portion 3712 is removed and replaced by a closed cover 3718. In a non-limiting example, the cover 3718 may not have any openings on it. Optionally, some embodiments may provide a septum or other closable opening in the cover, where the collecting portion 3712 may be removed without replacing the cover with a new part of a different configuration.

模組化樣本採集裝置Modular sample collection device

現請參考圖53A-53C，儘管本文所述實施例通常將樣本採集裝置說明為具有轉接部分3750，將樣本採集部分3740與樣本儲存容器3760相連，應暸解，並未排除不具有此種配置之實施例。 Referring now to FIGS. 53A-53C, although the embodiments described herein generally illustrate the sample collection device as having an adapter portion 3750, connecting the sample collection portion 3740 to the sample storage container 3760, it should be understood that this configuration is not excluded的 实施 例。 Examples.

如圖53A之非限制性實例繪示，一條或多條轉接部分3750可為最初與採集部分3740或樣本儲存容器3760皆不直接液體連通之分開元件。本文中，採集部分3740可籍由採集部分、轉接部分3750或容器3760(依序或同時)之一或更多者間的相對運動而與容器3760相連，以產生自採集通道通過一條或多條轉接通道進入容器之液體路徑。 As shown in the non-limiting example of FIG. 53A, one or more adapter portions 3750 may be separate elements that are not in direct liquid communication with either the collection portion 3740 or the sample storage container 3760 initially. Herein, the collection part 3740 may be connected to the container 3760 by relative movement between one or more of the collection part, the transfer part 3750 or the container 3760 (sequentially or simultaneously) to generate one or more channels from the collection channel An adapter channel enters the liquid path of the container.

如圖53B之非限制性實例繪示，如本文上文所述，一些實施例可不具有分開、單獨的轉接部分3750。本文中，採集部分3740與容器3760可籍由所述元件之一或兩者之間如箭頭3770所示之相對運動而直接相連。如圖53B所示，可設有液體流動特徵3780，其具有所述元件之一或兩者之間如箭頭3782所示之相對運動。於一個非限制性實例中，此液體流動特徵3780可為與採集部分3740一端結合之蓋，以促進流入容器3760之液體流。可選地，此液體流動特徵3780可為具有成型為與採集部分3740結合之前端的蓋。可選地，此液體流動特徵3780可為活塞、棒和/或其他裝置，以促進朝向樣本儲存容器3760之流動。可選地，此液體流動特徵3780未完全結合，直至樣本採集部分3740準備好與容器3760結合。可選地，一些實施例可經如此配置，即自採集部分3740至樣本儲存容器3760之流不使用液體流動特徵3780，與之相反，其乃是基於不同動力，諸如但不限於重力、真空吸力，或於採集部分3740合適末端處提供之吹力。 As shown in the non-limiting example of FIG. 53B, as described herein above, some embodiments may not have a separate, separate transition portion 3750. Here, the collecting part 3740 and the container 3760 may be directly connected by relative movement between one or both of the elements as shown by arrow 3770. As shown in FIG. 53B, a liquid flow feature 3780 may be provided that has relative movement between one or both of the elements as shown by arrow 3782. In one non-limiting example, this liquid flow feature 3780 may be a cap coupled to one end of the collection portion 3740 to facilitate liquid flow into the container 3760. Alternatively, this liquid flow feature 3780 may be a cover having a front end shaped to be combined with the collecting portion 3740. Alternatively, this liquid flow feature 3780 may be a piston, rod, and / or other device to facilitate flow toward the sample storage container 3760. Optionally, this liquid flow feature 3780 is not fully combined until the sample collection portion 3740 is ready to be combined with the container 3760. Alternatively, some embodiments may be configured such that the flow from the collection portion 3740 to the sample storage container 3760 does not use the liquid flow feature 3780, in contrast, it is based on different powers such as but not limited to gravity, vacuum suction , Or the blowing force provided at the appropriate end of the collecting part 3740.

如圖53C之非限制性實例繪示，一個或多個實施例可採用採集部分3740作為儲存容器。一些實施例可於所需填充程度達到後，簡單地將兩端皆蓋上蓋3790及3792。如圖53C所示，所述蓋3790及3792可將液體保持於其中，即使當部分3740處於垂直方向時。 As shown in the non-limiting example of FIG. 53C, one or more embodiments may employ the collection portion 3740 as a storage container. In some embodiments, after the required filling level is reached, both ends are simply covered with covers 3790 and 3792. As shown in FIG. 53C, the covers 3790 and 3792 can hold the liquid therein even when the portion 3740 is in the vertical direction.

可對本文所述之實施例做變動或替代，且所有實施例均不得解釋為涵蓋全部發明。舉例而言，採集部分 3740中係可設有兩條或更多條毛細管。可選地，其可各自形成為分開之管或通道。可選地，一些實施例可具有共同初始部分，惟具有分開之出口，諸如但不限於Y型構造。應瞭解，本文中任意實施例均可經修改以包括圖53A-53C所示特徵。 Changes or substitutions can be made to the embodiments described herein, and all embodiments should not be interpreted as covering all inventions. For example, the acquisition section The 3740 system can be equipped with two or more capillaries. Alternatively, they may each be formed as separate tubes or channels. Alternatively, some embodiments may have a common initial portion, but have separate outlets, such as but not limited to a Y-shaped configuration. It should be understood that any of the embodiments herein can be modified to include the features shown in FIGS. 53A-53C.

現請參考圖54，當樣本容器3800抵達所需處理目的地後，容器3800中的樣本可經適當地準備。於一個實施例中，容器3800類似於容器3710。如圖54所示，樣本可經處理，將一部分分入處理裝置，諸如但不限於匣3802之入口，及至另一匣3804之另一入口。於一個實施例中，兩個匣3802皆為微流體光碟，其處理樣本用於血液化學測試，諸如但不限於綜合代謝組合(ALB,ALP,ALT,AST,BUN,Ca,Cl-,CRE,GLU,K+,Na+,TBIL,tCO2,TP)、基礎代謝組合(BUN,Ca,CRE,eGFR,GLU,Cl-,K+,Na+,tCO2)、脂質組合(CHOL,HDL,CHOL/HDL,LDL,TRIG,VLDL,nHDLc)；脂質組合加強型(tCHOL,HDL,CHOL/HDL Ratio,LDL,TRIG,VLDL,GLU,ALT,AST,nHDLc)；肝組合加強型(ALB,ALP,ALT,AST,AMY,TBIL,TP,GGT)；電解質組合(Cl-,K+,Na+,tCO2)；一般化學(ALB,ALP,ALT,AMY,AST,BUN,Ca,CRE,eGFR,GGT,GLU,TBIL,TP,UA)；一般化學6(ALT,AST,CRE,eGFR,GLU,BUN,GGT)；腎功能組合(ALB,BUN,Ca,CRE,eGFR,GLU,Cl-,K+,Na+,tCO2 PHOS)；Metlyte(Cl-,K+,Na+,tCO2, BUN,CK,CRE,eGFR,GLU)；腎功能(BUN,CRE,eGFR；肝功能組合(ALB,ALP,ALT,AST,DBIL,TBIL,TP)；基礎代謝組合(BUN,Ca,CRE,eGFR,GLU,Cl-,K+,Na+,tCO2,Mg,LDH)；MetLyte Plus CRP(Cl-,K+,Na+,tCO2,BUN,CK,CRE,eGFR,GLU,CRP)；生化組合加強型(ALB,ALP,ALT,AMY,AST,BUN,Ca,CRE,eGFR,CRP,GGT,GLU,TP,UA)；MetLac(ALB,BUN,Ca,Cl-,CRE,GLU,K+,LAC,Mg,Na+,Phos,tCO2)。 Referring now to FIG. 54, when the sample container 3800 reaches the desired processing destination, the sample in the container 3800 can be properly prepared. In one embodiment, the container 3800 is similar to the container 3710. As shown in FIG. 54, the sample can be processed to divide a portion into a processing device, such as but not limited to the inlet of the cassette 3802, and another inlet to another cassette 3804. In one embodiment, both cartridges 3802 are microfluidic discs, which process samples for blood chemistry tests, such as but not limited to comprehensive metabolic combinations (ALB, ALP, ALT, AST, BUN, Ca, Cl-, CRE, GLU, K +, Na +, TBIL, tCO2, TP), basic metabolic combinations (BUN, Ca, CRE, eGFR, GLU, Cl-, K +, Na +, tCO2), lipid combinations (CHOL, HDL, CHOL / HDL, LDL, TRIG, VLDL, nHDLc); lipid combination enhanced (tCHOL, HDL, CHOL / HDL Ratio, LDL, TRIG, VLDL, GLU, ALT, AST, nHDLc); liver combination enhanced (ALB, ALP, ALT, AST, AMY , TBIL, TP, GGT); electrolyte combination (Cl-, K +, Na +, tCO2); general chemistry (ALB, ALP, ALT, AMY, AST, BUN, Ca, CRE, eGFR, GGT, GLU, TBIL, TP, UA); General Chemistry 6 (ALT, AST, CRE, eGFR, GLU, BUN, GGT); renal function combinations (ALB, BUN, Ca, CRE, eGFR, GLU, Cl-, K +, Na +, tCO2 PHOS); Metlyte (Cl-, K +, Na +, tCO2, BUN, CK, CRE, eGFR, GLU); renal function (BUN, CRE, eGFR; liver function combination (ALB, ALP, ALT, AST, DBIL, TBIL, TP); basic metabolic combination (BUN, Ca, CRE, eGFR , GLU, Cl-, K +, Na +, tCO2, Mg, LDH); MetLyte Plus CRP (Cl-, K +, Na +, tCO2, BUN, CK, CRE, eGFR, GLU, CRP); biochemical combination enhanced (ALB, ALP, ALT, AMY, AST, BUN, Ca, CRE, eGFR, CRP, GGT, GLU, TP, UA); MetLac (ALB, BUN, Ca, Cl-, CRE, GLU, K +, LAC, Mg, Na +, Phos, tCO2).

現請參考圖55，應瞭解，一些實施例可採用樣本操作系統，其具有吸量管或類似物以無管方式自容器3800抽取樣本。圖55顯示，可運用自動系統整分樣本。還應應瞭解，於一些實施例中，於整分之前、之中或之後，可執行樣本稀釋，以提高樣本之液體體積。這可有利於各種用途。圖55亦顯示，於一些實施例中，可將樣本送至一般化學微流體/離心分離匣3802。還可使用至少一個或多個其他匣改良可得測試類型，所述其他匣諸如但不限於經引用被合併於此的申請案所述開放液體移動型匣。測試可包括使用其他檢測技術增加除使用匣3802之一般化學測試外可完成之分析類型，所述其他檢測技術諸如但不限於ELISA、核酸擴增、顯微術、分光光度法、電化學和/或其他檢測技術。可選地，應瞭解，本文中，可與從容器3800中整分之系統一起，運用超過一個匣3802和/或3806。 Referring now to FIG. 55, it should be understood that some embodiments may employ a sample operating system with a pipette or the like to draw samples from the container 3800 in a tubeless manner. Figure 55 shows that an automated system can be used to divide the sample. It should also be understood that in some embodiments, sample dilution may be performed before, during, or after aliquoting to increase the liquid volume of the sample. This can be beneficial for various uses. Figure 55 also shows that in some embodiments, the sample can be sent to a general chemical microfluidic / centrifugal separation cartridge 3802. At least one or more other cartridges may also be used to modify the available test types, such as but not limited to the open liquid mobile cartridges described in the applications incorporated herein by reference. Testing can include the use of other detection techniques to increase the types of analysis that can be done in addition to the general chemical tests using cassette 3802, such as but not limited to ELISA, nucleic acid amplification, microscopy, spectrophotometry, electrochemistry, and / Or other detection techniques. Alternatively, it should be understood that more than one cassette 3802 and / or 3806 may be used in conjunction with the system that divides from the container 3800 herein.

現請參考圖56A及56B，運送容器4000可被配置為其中容納採自複數個諸如病患等對象之複數個體液樣本。於一些實施例中，採自各對象之樣本係處於多個器皿中。可選地，採自同一對象之至少兩個樣本接受不同化學前處理，諸如但不限於各器皿中的不同抗凝劑。可選地，一些實施例可使用具有兩個或更多個單獨室之器皿，其中各室被配置為容納與另一室中液體樣本分開之液體樣本一部分。一些實施例可於單室器皿和/或多室器皿中包括採自某一對象之樣本。 Referring now to FIGS. 56A and 56B, the shipping container 4000 may be configured to contain a plurality of individual fluid samples taken from a plurality of subjects such as patients. In some embodiments, the samples taken from each subject are in multiple vessels. Optionally, at least two samples taken from the same subject undergo different chemical pretreatments, such as but not limited to different anticoagulants in each vessel. Alternatively, some embodiments may use vessels with two or more separate chambers, where each chamber is configured to hold a portion of the liquid sample that is separate from the liquid sample in another chamber. Some embodiments may include samples taken from an object in single-chamber vessels and / or multi-chamber vessels.

圖56A及56B繪示運送容器4000的各種視圖，其中蓋4010具有至少檯面部分4012，其尺寸適合進入容器4000底部上的凹陷4020，如圖57A所示，使得容器4000可堆疊。容器4000可具有本文所述其他運送容器實施例中說明之任意特徵。 FIGS. 56A and 56B illustrate various views of the shipping container 4000, where the lid 4010 has at least a table portion 4012 that is sized to enter a recess 4020 on the bottom of the container 4000, as shown in FIG. 57A, so that the containers 4000 can be stacked. The container 4000 may have any of the features described in other shipping container embodiments described herein.

圖57B繪示，容器4000中可設有托盤4030，其可固定於容器4000和/或從其上移除。於一個實施例中，托盤4030籍由固定裝置固定在位，所述固定裝置諸如但不限於與容器4000底盤中金屬或磁性部分對齊之磁性或金屬部分4032，以形成磁連接。於一些實施例中，長寬縱橫比處於約128：86至127：85的範圍內。可選地，長寬縱橫比處於約130：90至120：80的範圍內。可選地，托盤長度處於約130mm至120mm的範圍內，寬度則處於約90mm至80mm的範圍內。於一些實施例中，托盤高度或厚度處於約14至20mm的範圍內。所述縱橫比和/或尺寸被配置為 固定其尺寸適合平板離心分離機上的槽、凹陷或其他支座的托盤。以此方式，整個托盤4030可經離心準備其中複數個樣本。 57B illustrates that a tray 4030 may be provided in the container 4000, which may be fixed to and / or removed from the container 4000. In one embodiment, the tray 4030 is fixed in place by a fixing device, such as but not limited to a magnetic or metal portion 4032 aligned with the metal or magnetic portion in the chassis of the container 4000 to form a magnetic connection. In some embodiments, the aspect ratio is in the range of about 128: 86 to 127: 85. Optionally, the length to width aspect ratio is in the range of about 130: 90 to 120: 80. Optionally, the length of the tray is in the range of about 130 mm to 120 mm, and the width is in the range of about 90 mm to 80 mm. In some embodiments, the tray height or thickness is in the range of about 14 to 20 mm. The aspect ratio and / or size are configured as Fix the tray whose size is suitable for the groove, depression or other support on the plate centrifuge. In this way, the entire tray 4030 can be centrifuged to prepare a plurality of samples therein.

如圖57B及58B所示，托盤4030具有複數個槽4034，其中槽4034尺寸設為固定至少一個樣本儲存器皿。槽4034的至少一部分4040具有第一形狀，至少第二部分4042具有與第一形狀不同之第二形狀，其中所述形狀以如此方式鍵合：樣本器皿僅能以所需方向被***槽4034中。如圖58B所示，一端為半圓形，而另一端為非對稱形狀。托盤4030亦可成型為具有凹陷4036或其他形狀，使得托盤4030僅能以一種方向被***運送容器4000中。還應瞭解，托盤4030可被固定於托盤中，使得使用者不可僅使用手指，而不運用工具或其他托盤抽取裝置將其從容器4000中移除。這將使用者破壞之風險降至最低。托盤4030可被配置為即使當容器4000上下倒轉時，亦可被固定於運送容器4000中，且能抵制地球重力之牽拉。 As shown in FIGS. 57B and 58B, the tray 4030 has a plurality of grooves 4034, wherein the size of the groove 4034 is set to fix at least one sample storage vessel. At least a portion 4040 of the groove 4034 has a first shape, and at least a second portion 4042 has a second shape different from the first shape, wherein the shapes are bonded in such a manner that the sample vessel can only be inserted into the groove 4034 in a desired direction . As shown in FIG. 58B, one end has a semicircular shape, and the other end has an asymmetric shape. The tray 4030 may also be shaped to have recesses 4036 or other shapes so that the tray 4030 can be inserted into the shipping container 4000 in only one direction. It should also be understood that the tray 4030 may be fixed in the tray so that the user cannot use his fingers only to remove it from the container 4000 without using tools or other tray extraction devices. This minimizes the risk of user destruction. The tray 4030 can be configured to be fixed in the transport container 4000 even when the container 4000 is turned upside down, and can resist the gravity of the earth.

圖59A及59B繪示另一實施例，其中托盤4102中係有複數個槽4100。托盤可具有不同縱橫比(較接近正方形)，且托盤中具有複數個成型槽以固定樣本器皿。 59A and 59B illustrate another embodiment, in which a plurality of slots 4100 are formed in the tray 4102. The tray may have different aspect ratios (closer to a square), and the tray has a plurality of forming grooves to fix the sample vessel.

於至少一些實施例中，醫學供應商(或合適時其員工)可為樣本採集商、測試結果接收方和/或兩者皆可。舉例而言，於一個實施例中，諸如但不限於牙醫等保健業者可於牙科程序中或另行採集樣本。可選地，一些實施例可自病患的牙科程序中吸出的血液和/或唾液採集樣 本。所採集樣本可於牙醫診所和/或運送至接收複數個樣本加以處理之接收地點加以處理。 In at least some embodiments, the medical provider (or its employees as appropriate) may be the sample collector, the test result recipient, and / or both. For example, in one embodiment, health care providers such as but not limited to dentists may collect samples during dental procedures or separately. Optionally, some embodiments may collect samples from blood and / or saliva drawn from a patient's dental procedures this. The collected samples can be processed in a dentist's office and / or delivered to a receiving location where multiple samples are processed.

本文中所討論或引用之出版物僅因其於本申請案提交日期前之揭示而提供。本文任何內容不得被解釋為承認本發明無權憑藉先前發明而日期早於此等出版物。而且，所提供出版物日期可不同於其實際出版日期，其需經獨立確認。本文所提全部出版物籍由引用合併於此，以揭示並說明與所引用出版物相關之結構和/或方法。以下申請案籍由引用被完整合併於此，以用於所有目的：2011年1月21日提交之美國專利臨時申請案第61/435,250號(“用於樣本使用最大化之系統及方法”)及美國專利公告第2009/0088336號(“模組化護理點裝置、系統及其用途”)。以下申請案亦籍由引用被完整合併於此，以用於所有目的：美國專利公告第2005/0100937號、美國專利第8,380,541號；2013年2月18日提交之美國專利申請案第61/766,113號；2013年2月18日提交之美國專利申請案第13/769,798號；2013年2月18日提交之美國專利申請案第13/769,779號；2013年2月18日提交之美國專利申請案第13/769,820號；2011年9月26日提交之美國專利申請案第13/244,947號；2012年9月25日提交之PCT/US2012/57155；2011年9月26日提交之美國專利申請案第13/244,946號；2011年9月26日提交之美國專利申請案第13/244,949號；及2011年9月26日提交之美國專利申請案第61/673,245號，所述專利及專利申請案均籍由引 用被完整合併於此。 The publications discussed or cited in this article are provided solely for their disclosure before the filing date of this application. Nothing in this document should be construed as an admission that the invention is not entitled to earlier publications based on previous inventions. Furthermore, the dates of publications provided may be different from their actual publication dates, which need to be independently confirmed. All publications mentioned herein are incorporated by reference to reveal and explain the structure and / or methods related to the cited publications. The following applications are fully incorporated by reference for all purposes: US Patent Provisional Application No. 61 / 435,250, filed on January 21, 2011 ("System and Method for Maximizing Sample Use") And U.S. Patent Announcement No. 2009/0088336 ("Modular point-of-care devices, systems, and uses"). The following applications are also fully incorporated by reference for all purposes: US Patent Publication No. 2005/0100937, US Patent No. 8,380,541; US Patent Application No. 61 / 766,113 filed on February 18, 2013 No .; US Patent Application No. 13 / 769,798 filed on February 18, 2013; US Patent Application No. 13 / 769,779 filed on February 18, 2013; US Patent Application filed on February 18, 2013 No. 13 / 769,820; US Patent Application No. 13 / 244,947 filed on September 26, 2011; PCT / US2012 / 57155 filed on September 25, 2012; US Patent Application filed on September 26, 2011 No. 13 / 244,946; U.S. Patent Application No. 13 / 244,949 filed on September 26, 2011; and U.S. Patent Application No. 61 / 673,245 filed on September 26, 2011, said patents and patent applications All cited The application is completely incorporated here.

實施例 Examples

於本文所述一個實施例中，係提供有一種自對象採集體液樣本之裝置，包括：至少兩條樣本採集路徑，其被配置為自所述裝置與對象接觸之單個端抽取體液樣本入裝置中，由此將液體樣本分為兩個單獨樣本；一第二部分，其包括複數個樣本容器用於接收樣本採集路徑中採集的體液樣本，所述樣本容器可***作地可與樣本採集路徑形成液體連通，由此當液體連通形成後，容器提供動力將所述兩個單獨樣本之多數從所述路徑移入所述容器中。 In one embodiment described herein, a device for collecting a body fluid sample from a subject is provided, including: at least two sample collection paths configured to draw a body fluid sample into the device from a single end of the device in contact with the subject , Thereby dividing the liquid sample into two separate samples; a second part, which includes a plurality of sample containers for receiving body fluid samples collected in the sample collection path, the sample container can be operably formed with the sample collection path Liquid communication, whereby when liquid communication is formed, the container provides power to move the majority of the two separate samples from the path into the container.

於本文所述另一實施例中，係提供有一種採集體液樣本之裝置，包括：一第一部分，其包括至少一個液體採集位置，通向至少兩條被配置為籍由第一類型動力抽取其中液體樣本的樣本採集路徑；一第二部分，其包括複數個樣本容器用於接收樣本採集路徑中採集的體液樣本，所述樣本容器可***作地可與樣本採集路徑形成液體連通，由此當液體連通形成後，容器提供不同於第一動力之第二動力將體液樣本之多數從所述路徑移入所述容器中；其中，樣本採集路徑中至少一條具有填充指示器，指示最低填充程度何時達到，且至少一個樣本容器可與至少一條樣本採集路徑形成液體連通。 In another embodiment described herein, there is provided a device for collecting a body fluid sample, including: a first part including at least one liquid collection position, leading to at least two of which are configured to be drawn by a first type of power A sample collection path of a liquid sample; a second part, which includes a plurality of sample containers for receiving body fluid samples collected in the sample collection path, the sample container can be operably formed in liquid communication with the sample collection path, thereby After the liquid communication is formed, the container provides a second power different from the first power to move the majority of body fluid samples from the path into the container; wherein, at least one of the sample collection paths has a filling indicator indicating when the minimum filling level is reached , And at least one sample container may be in liquid communication with at least one sample collection path.

於本文所述另一實施例中，係提供有一種採集體液樣本之裝置，包括：一第一部分，其包括至少兩條被配置為籍由第一類型動力抽取液體樣本進入樣本採集通道 的樣本採集通道，其中一條樣本採集通道具有設計為與液體樣本混合之內部塗層，另一條樣本採集通道具有化學不同於所述內部塗層之另一內部塗層；一第二部分，其包括複數個樣本容器用於接收樣本採集通道中採集的體液樣本，所述樣本容器可***作地可與採集通道形成液體連通，由此當液體連通形成後，容器提供不同於第一動力之第二動力將體液樣本之多數從所述通道移入所述容器中；其中，容器如此放置，使得各容器中的液體樣本不會彼此混合。 In another embodiment described herein, a device for collecting a body fluid sample is provided, including: a first portion including at least two liquid samples that are configured to be drawn by a first type of power into a sample collection channel Sample collection channel, where one sample collection channel has an internal coating designed to mix with a liquid sample, and the other sample collection channel has another internal coating that is chemically different from the internal coating; a second part, which includes A plurality of sample containers are used to receive the body fluid sample collected in the sample collection channel, the sample container is operable to form a liquid communication with the collection channel, whereby when the liquid communication is formed, the container provides a second different from the first power The power moves the majority of body fluid samples from the channel into the container; where the containers are placed so that the liquid samples in each container do not mix with each other.

於本文所述另一實施例中，係提供有一種採集體液樣本之裝置，包括：一第一部分，其包括複數條樣本採集通道，其中至少兩條通道被配置為籍由第一類型動力同時抽取液體樣本進入所述至少兩條樣本採集通道中的每一條；一第二部分，其包括複數個樣本容器用於接收樣本採集通道中採集的體液樣本，其中所述樣本容器具有第一狀態，即樣本容器不與樣本採集通道處於液體連通中，及第二狀態，即樣本容器可***作地可與採集通道形成液體連通，由此當液體連通形成後，容器提供不同於第一動力之第二動力將體液樣本之多數從所述通道移入所述容器中。 In another embodiment described herein, a device for collecting body fluid samples is provided, including: a first part including a plurality of sample collection channels, wherein at least two channels are configured to be simultaneously drawn by a first type of power The liquid sample enters each of the at least two sample collection channels; a second part, which includes a plurality of sample containers for receiving body fluid samples collected in the sample collection channel, wherein the sample container has a first state, ie The sample container is not in liquid communication with the sample collection channel, and the second state, that is, the sample container can be operatively formed in liquid communication with the collection channel, whereby when liquid communication is formed, the container provides a second different from the first power The power moves the majority of the body fluid sample from the channel into the container.

於本文所述另一實施例中，係提供有一種樣本採集裝置，包括：(a)一採集通道，其包括第一開口及第二開口，且被配置為籍由毛細作用將體液樣本自第一開口朝第二開口抽吸；及(b)一樣本容器，用於接收體液樣 本，所述容器可與採集通道結合，具有其中為真空之內部，並具有配置為接收通道之蓋；其中第二開口由採集通道之一部分限定，其被配置為穿透樣本容器蓋，並提供採集通道與樣本容器之間的液體流動路徑，且樣本容器的內部體積不大於採集通道內部體積的十倍。 In another embodiment described herein, there is provided a sample collection device, including: (a) a collection channel, which includes a first opening and a second opening, and is configured to use capillary action to sample a body fluid from the first One opening draws towards the second opening; and (b) a container for receiving body fluid samples In this case, the container can be combined with the collection channel, has an interior therein that is vacuum, and has a lid configured to receive the channel; wherein the second opening is defined by a portion of the collection channel, which is configured to penetrate the sample container lid and provide The liquid flow path between the collection channel and the sample container, and the internal volume of the sample container is not greater than ten times the internal volume of the collection channel.

於本文所述另一實施例中，係提供有一種樣本採集裝置，包括：(a)一採集通道，其包括第一開口及第二開口，且被配置為籍由毛細作用將體液樣本自第一開口朝第二開口抽吸；(b)一樣本容器，用於接收體液樣本，所述容器可與採集通道結合，具有其中為真空之內部，並具有配置為接收通道之蓋；及(c)一轉接通道，其被配置為提供採集通道與樣本容器之間的液體流動路徑，具有第一開口及第二開口，第一開口被配置為與採集通道第二開口接觸，第二開口被配置為穿透樣本容器蓋。 In another embodiment described herein, there is provided a sample collection device, including: (a) a collection channel, which includes a first opening and a second opening, and is configured to use capillary action to sample a body fluid from the first One opening draws towards the second opening; (b) a sample container for receiving a sample of body fluid, the container can be combined with a collection channel, has an interior therein which is vacuum, and has a lid configured to receive the channel; and (c ) An adapter channel, which is configured to provide a liquid flow path between the collection channel and the sample container, has a first opening and a second opening, the first opening is configured to contact the second opening of the collection channel, and the second opening is Configured to penetrate the sample container lid.

於本文所述另一實施例中，係提供有一種樣本採集裝置，包括：(a)一本體，包含一條採集通道，該採集通道包括第一開口及第二開口，且被配置為籍由毛細作用將體液自第一開口朝第二開口抽吸；(b)一基座，包含一個樣本容器用於接收體液樣本，所述樣本容器可與採集通道結合，具有其中為真空之內部，並具有配置為接收通道之蓋；及(c)一支架，其中本體及基座被連接至支架之相對端，且被配置為彼此可相對移動，使得樣本採集裝置被配置為具有延伸狀態及壓縮狀態，其中基座至少一部分於裝置延伸狀態相較壓縮狀態距本體較近，採集通道第二 開口被配置為穿透樣本容器蓋，於裝置延伸狀態，採集通道第二開口不與樣本容器內部接觸，且於裝置壓縮狀態，採集通道第二開口透過容器蓋延伸進入樣本容器內部，由此提供採集通道與樣本容器之間的液體連通。 In another embodiment described herein, a sample collection device is provided, including: (a) a body including a collection channel, the collection channel includes a first opening and a second opening, and is configured to be capillary The function of sucking body fluid from the first opening towards the second opening; (b) a base, which contains a sample container for receiving a sample of body fluid, the sample container can be combined with the collection channel, has an interior in which is a vacuum, and has A cover configured to receive the channel; and (c) a support, wherein the body and the base are connected to opposite ends of the support and are configured to move relative to each other, so that the sample collection device is configured to have an extended state and a compressed state At least a part of the base is closer to the body in the extended state of the device than in the compressed state, and the acquisition channel is second The opening is configured to penetrate the sample container cover. In the extended state of the device, the second opening of the collection channel does not contact the inside of the sample container, and in the compressed state of the device, the second opening of the collection channel extends through the container cover into the interior of the sample container, thereby providing The liquid communication between the collection channel and the sample container.

於本文所述另一實施例中，係提供有一種樣本採集裝置，包括：(a)一本體，包含一條採集通道，該採集通道包括第一開口及第二開口，且被配置為籍由毛細作用將體液自第一開口朝第二開口抽吸；(b)一基座，包含一個樣本容器用於接收體液樣本，所述樣本容器可與採集通道結合，具有其中為真空之內部，並具有配置為接收通道之蓋；(c)一支架，及(d)一轉接通道，其具有第一開口及第二開口，第一開口被配置為與採集通道第二開口接觸，第二開口被配置為穿透樣本容器蓋，其中本體及基座被連接至支架之相對端，且被配置為彼此可相對移動，使得樣本採集裝置被配置為具有延伸狀態及壓縮狀態，其中基座至少一部分於裝置延伸狀態相較壓縮狀態距本體較近，於裝置延伸狀態，轉接通道不與採集通道及樣本容器內部之一或兩者皆接觸，且於裝置壓縮狀態，轉接通道第一開口與採集通道第二開口接觸，且轉接通道第二開口透過容器蓋延伸進入樣本容器內部，由此提供採集通道與樣本容器之間的液體連通。 In another embodiment described herein, a sample collection device is provided, including: (a) a body including a collection channel, the collection channel includes a first opening and a second opening, and is configured to be capillary The function of sucking body fluid from the first opening towards the second opening; (b) a base, which contains a sample container for receiving a sample of body fluid, the sample container can be combined with the collection channel, has an interior in which is a vacuum, and has A cover configured to receive the channel; (c) a bracket, and (d) an adaptor channel having a first opening and a second opening, the first opening is configured to contact the second opening of the collection channel, the second opening is Configured to penetrate the sample container lid, wherein the body and the base are connected to opposite ends of the holder, and are configured to be relatively movable relative to each other, so that the sample collection device is configured to have an extended state and a compressed state, wherein at least a portion of the base is The extended state of the device is closer to the body than the compressed state. In the extended state of the device, the transfer channel is not in contact with one or both of the collection channel and the sample container, and in the compressed state of the device, the first opening of the transfer channel and the collection The second opening of the channel contacts, and the second opening of the transition channel extends through the container lid into the interior of the sample container, thereby providing liquid communication between the collection channel and the sample container.

於本文所述另一實施例中，係提供有一種自對象採集液體樣本之裝置，包括：(a)一本體，包含一條採集通道，該採集通道包括第一開口及第二開口，且被配置 為籍由毛細作用將體液自第一開口朝第二開口抽吸；(b)一可與本體接合之基座，其中基座支持樣本容器，所述容器可與採集通道接合，具有其中為真空之內部，並具有配置為接收通道之蓋；其中採集通道第二開口被配置為穿透樣本容器蓋，並提供採集通道與樣本容器之間的液體流動路徑。 In another embodiment described herein, a device for collecting a liquid sample from a subject is provided, including: (a) a body including a collection channel, the collection channel includes a first opening and a second opening, and is configured To suck the body fluid from the first opening toward the second opening by capillary action; (b) a base that can be engaged with the body, wherein the base supports a sample container, the container can be engaged with the collection channel, and has a vacuum therein Inside, and has a cover configured to receive the channel; wherein the second opening of the collection channel is configured to penetrate the sample container cover and provide a liquid flow path between the collection channel and the sample container.

於本文所述另一實施例中，係提供有一種自對象採集液體樣本之裝置，包括：(a)一本體，包含一條採集通道，該採集通道包括第一開口及第二開口，且被配置為籍由毛細作用將體液自第一開口朝第二開口抽吸；(b)一可與本體接合之基座，其中基座支持樣本容器，所述樣本容器可與採集通道接合，具有其中為真空之內部，並具有配置為接收通道之蓋；及(c)一轉接通道，其具有第一開口及第二開口，第一開口被配置為與採集通道第二開口接觸，第二開口被配置為穿透樣本容器蓋。 In another embodiment described herein, a device for collecting a liquid sample from a subject is provided, including: (a) a body including a collection channel, the collection channel includes a first opening and a second opening, and is configured To suck the body fluid from the first opening toward the second opening by capillary action; (b) a base that can be engaged with the body, wherein the base supports a sample container, the sample container can be engaged with the collection channel, and has The inside of the vacuum, and has a cover configured to receive the channel; and (c) an adapter channel having a first opening and a second opening, the first opening is configured to contact the second opening of the collection channel, the second opening Configured to penetrate the sample container lid.

應瞭解，一個或多個以下特徵皆可適用於本文所述之任一實施例中。作為非限制性實例，本體可包含兩條採集通道。可選地，採集通道內部可塗覆有抗凝劑。可選地，本體具有第一採集通道及第二採集通道，且第一採集通道內部塗覆有不同於第二採集通道內部之抗凝劑。可選地，第一抗凝劑為乙二胺四乙酸(EDTA)，而第二抗凝劑不同於EDTA。可選地，第一抗凝劑為檸檬酸鹽，而第二抗凝劑不同於檸檬酸鹽。可選地，第一抗凝劑為肝磷脂，而第二抗凝劑不同於肝磷脂。可選地，一種抗凝劑為 肝磷脂，而第二抗凝劑為EDTA。可選地，一種抗凝劑為肝磷脂，而第二抗凝劑為檸檬酸鹽。可選地，一種抗凝劑為檸檬酸鹽，而第二抗凝劑為EDTA。可選地，本體用光透射材料製成。可選地，裝置包含的樣本容器數目與採集通道數目相同。可選地，裝置包含的轉接通道數目與採集通道數目相同。可選地，基座包含光學指示器，其提供樣本是否到達基座中樣本容器之視覺指示。可選地，基座為一個窗口，其允許使用者觀察基座中的容器。可選地，支架包括彈簧，而彈簧施加作用力，使得當裝置處於其自然狀態時，裝置處於延伸狀態。可選地，採集通道或轉接通道第二開口可籍由套管封蓋，其中所述套管不阻止體液籍由毛細作用自第一開口朝第二開口之移動。可選地，所述套管包含排氣口。可選地，各採集通道可容納不大於500uL的體積。可選地，各採集通道可容納不大於200uL的體積。可選地，各採集通道可容納不大於100uL的體積。可選地，各採集通道可容納不大於70uL的體積。可選地，各採集通道可容納不大於500uL的體積。可選地，各採集通道可容納不大於30uL的體積。可選地，各採集通道剖面之內周長不大於16mm。可選地，各採集通道剖面之內周長不大於8mm。可選地，各採集通道剖面之內周長不大於4mm。可選地，所述內周長為圓周。可選地，裝置包括第一及第二採集通道，第一通道開口鄰近第二通道開口，且所述開口被配置為從單滴血液同時抽取血液。可選地，第一通道開口與第二通道開口之中心距小於或等 於約5mm。可選地，各樣本容器內部體積不大於其可接合採集通道之內部體積的二十倍。可選地，各樣本容器內部體積不大於其可接合採集通道之內部體積的十倍。可選地，各樣本容器內部體積不大於其可接合採集通道之內部體積的五倍。可選地，各樣本容器內部體積不大於其可接合採集通道之內部體積的二倍。可選地，採集通道與樣本容器之間液體連通之形成導致採集通道中至少90%的體液樣本被傳遞進入樣本容器中。 It should be understood that one or more of the following features can be applied to any of the embodiments described herein. As a non-limiting example, the ontology may contain two acquisition channels. Optionally, an anticoagulant may be coated inside the collection channel. Optionally, the body has a first collection channel and a second collection channel, and the first collection channel is coated with an anticoagulant different from the inside of the second collection channel. Alternatively, the first anticoagulant is ethylenediaminetetraacetic acid (EDTA), and the second anticoagulant is different from EDTA. Alternatively, the first anticoagulant is citrate, and the second anticoagulant is different from citrate. Alternatively, the first anticoagulant is heparin, and the second anticoagulant is different from heparin. Optionally, an anticoagulant is Heparin, and the second anticoagulant is EDTA. Optionally, one anticoagulant is heparin and the second anticoagulant is citrate. Optionally, one anticoagulant is citrate and the second anticoagulant is EDTA. Optionally, the body is made of a light-transmitting material. Optionally, the number of sample containers included in the device is the same as the number of collection channels. Optionally, the number of switching channels included in the device is the same as the number of collecting channels. Optionally, the base contains an optical indicator that provides a visual indication of whether the sample has reached the sample container in the base. Optionally, the base is a window that allows the user to view the container in the base. Optionally, the stand includes a spring, and the spring exerts a force so that when the device is in its natural state, the device is in an extended state. Optionally, the second opening of the collection channel or the transition channel can be covered by a sleeve, wherein the sleeve does not prevent the movement of body fluid from the first opening to the second opening by capillary action. Optionally, the sleeve contains an exhaust port. Optionally, each collection channel can accommodate a volume no greater than 500 uL. Optionally, each collection channel can accommodate a volume no greater than 200 uL. Optionally, each collection channel can accommodate a volume no greater than 100 uL. Optionally, each collection channel can accommodate a volume no greater than 70 uL. Optionally, each collection channel can accommodate a volume no greater than 500 uL. Optionally, each collection channel can accommodate a volume no greater than 30 uL. Optionally, the inner circumference of each acquisition channel profile is not greater than 16mm. Optionally, the inner circumference of each acquisition channel profile is not greater than 8 mm. Optionally, the inner circumference of each acquisition channel profile is not greater than 4 mm. Optionally, the inner circumference is a circumference. Optionally, the device includes first and second collection channels, the first channel opening is adjacent to the second channel opening, and the opening is configured to simultaneously draw blood from a single drop of blood. Optionally, the center distance between the first channel opening and the second channel opening is less than or equal At about 5mm. Optionally, the internal volume of each sample container is not greater than twenty times the internal volume of the sample channel it can engage. Optionally, the internal volume of each sample container is not greater than ten times the internal volume of the sample channel it can engage. Optionally, the internal volume of each sample container is not greater than five times the internal volume of the sample channel it can engage. Optionally, the internal volume of each sample container is not greater than twice the internal volume of the sample channel it can engage. Optionally, the formation of liquid communication between the collection channel and the sample container causes at least 90% of the body fluid sample in the collection channel to be transferred into the sample container.

應瞭解，一個或多個以下特徵皆可適用於本文所述之任一實施例中。可選地，採集通道與樣本容器之間液體連通之形成導致採集通道中至少95%的體液樣本被傳遞進入樣本容器中。可選地，採集通道與樣本容器之間液體連通之形成導致採集通道中至少98%的體液樣本被傳遞進入樣本容器中。可選地，採集通道與樣本容器之間液體連通之形成導致體液樣本被傳遞進入樣本容器中，且不超過10uL的體液樣本殘留於採集通道中。可選地，採集通道與樣本容器之間液體連通之形成導致體液樣本被傳遞進入樣本容器中，且不超過5uL的體液樣本殘留於採集通道中。可選地，採集通道與樣本容器之間液體連通之形成導致體液樣本被傳遞進入樣本容器中，且不超過2uL的體液樣本殘留於採集通道中。 It should be understood that one or more of the following features can be applied to any of the embodiments described herein. Optionally, the formation of liquid communication between the collection channel and the sample container causes at least 95% of the body fluid sample in the collection channel to be transferred into the sample container. Optionally, the liquid communication between the collection channel and the sample container results in at least 98% of the body fluid sample in the collection channel being transferred into the sample container. Optionally, the formation of liquid communication between the collection channel and the sample container causes the body fluid sample to be transferred into the sample container, and no more than 10 uL of the body fluid sample remains in the collection channel. Optionally, the formation of liquid communication between the collection channel and the sample container causes the body fluid sample to be transferred into the sample container, and no more than 5 uL of the body fluid sample remains in the collection channel. Optionally, the formation of liquid communication between the collection channel and the sample container causes the body fluid sample to be transferred into the sample container, and no more than 2 uL of the body fluid sample remains in the collection channel.

於本文所述之另一實施例中，係提供有一種方法，其包括使樣本採集裝置一端與體液樣本接觸，籍由第一類型動力將樣本抽吸入樣本採集裝置之至少兩條採集通 道，由此將樣本分成至少兩個部分；於所需之量之樣本液體已被確認處於至少一條採集通道中後，建立樣本採集通道與樣本容器之間液體連通，由此所述容器提供不同於第一動力之第二動力將各體液樣本部分移入其各自容器中。 In another embodiment described herein, a method is provided that includes contacting one end of a sample collection device with a body fluid sample and drawing the sample into at least two collection channels of the sample collection device by a first type of power Channel, thereby dividing the sample into at least two parts; after the required amount of sample liquid has been confirmed to be in at least one collection channel, establish a liquid communication between the sample collection channel and the sample container, whereby the container provides a different The second power at the first power moves each body fluid sample portion into its respective container.

於本文所述之另一實施例中，係提供有一種方法，其包括使用一種具有至少兩條樣本採集通道之樣本採集裝置將最小量之樣本計量入至少兩條通道中，該至少兩條樣本採集通道配置為籍由一第一類型動力同時將該液體樣本抽吸入該至少兩條樣本採集通道中的每一條中；當所需之量之樣本液體已被確認處於採集通道中後，該等樣本採集通道與樣本容器之間實現液體連通，由此所述容器即提供與用於採集樣本的第一動力不同之第二動力，從而將體液樣本從該通道移至容器中。 In another embodiment described herein, a method is provided that includes using a sample collection device having at least two sample collection channels to meter a minimum amount of samples into at least two channels, the at least two samples The collection channel is configured to draw the liquid sample into each of the at least two sample collection channels simultaneously by a first type of power; when the required amount of sample liquid has been confirmed to be in the collection channel, the When the sample collection channel is in fluid communication with the sample container, the container provides a second power different from the first power used to collect the sample, thereby moving the body fluid sample from the channel to the container.

於本文所述之另一實施例中，係提供有一種採集體液樣本之方法，其包括(a)運用包含採集通道之裝置接觸體液樣本，該採集通道包括第一開口及第二開口，且被配置為籍由毛細作用將體液自第一開口朝第二開口抽吸，使得體液樣本自第一開口至第二開口填滿採集通道；(b)建立採集通道與樣本容器內部之間的液體流動路徑，所述樣本容器的內部體積不大於採集通道內部體積的十倍，且於採集通道與樣本容器內部之間的液體流動路徑建立前具有真空，使得採集通道與樣本容器內部之間的液體流動路徑建立於採集通道第二開口處產生負壓，且液體樣本自採集通道被傳遞至樣本容器內部。 In another embodiment described herein, a method for collecting a body fluid sample is provided, which includes (a) contacting a body fluid sample with a device including a collection channel, the collection channel includes a first opening and a second opening, and is It is configured to suck the body fluid from the first opening toward the second opening by capillary action, so that the body fluid sample fills the collection channel from the first opening to the second opening; (b) establish a liquid flow between the collection channel and the interior of the sample container Path, the internal volume of the sample container is not greater than ten times the internal volume of the collection channel, and there is a vacuum before the liquid flow path between the collection channel and the interior of the sample container is established, so that the liquid flow between the collection channel and the interior of the sample container The path is established at the second opening of the collection channel to generate negative pressure, and the liquid sample is transferred from the collection channel to the inside of the sample container.

於本文所述之另一實施例中，係提供有一種採集體液樣本之方法，其包括(a)運用本文所述任意採集裝置接觸體液樣本，使得體液樣本自裝置中至少一條採集通道之第一開口至其第二開口填滿採集通道；及(b)建立採集通道與樣本容器內部之間的液體流動路徑，使得採集通道與樣本容器內部之間的液體流動路徑建立於採集通道第二開口處產生負壓，且液體樣本自採集通道被傳遞至樣本容器內部。 In another embodiment described herein, a method for collecting a body fluid sample is provided, which includes (a) contacting a body fluid sample with any collection device described herein so that the body fluid sample is from the first of at least one collection channel in the device Opening to its second opening to fill the collection channel; and (b) establishing a liquid flow path between the collection channel and the interior of the sample container, such that the liquid flow path between the collection channel and the interior of the sample container is established at the second opening of the collection channel A negative pressure is generated, and the liquid sample is transferred from the collection channel to the inside of the sample container.

應瞭解，一個或多個以下特徵皆可適用於本文所述之任一實施例中。可選地，採集通道與樣本容器內部之間不形成液體連通，直至體液到達採集通道第二開口。可選地，裝置包括兩條採集通道，且採集通道與樣本容器內部之間不形成液體連通，直至兩條採集通道之第二開口皆有體液到達。可選地，裝置中採集通道第二開口被配置為穿透樣本容器蓋，且其中籍由提供採集通道第二開口與樣本容器之間的相對運動，形成採集通道第二開口與樣本容器之間的液體流動路徑，使得採集通道第二開口穿透樣本容器蓋。可選地，裝置為裝置中各條採集通道設有轉接通道，所述轉接通道具有第一開口及第二開口，第一開口被配置為與採集通道第二開口接觸，第二開口被配置為穿透樣本容器蓋，且其中籍由提供(a)採集通道第二開口，(b)轉接通道及(c)樣本容器中兩者或更多者之間的相對運動，形成採集通道與樣本容器之間的液體流動路徑，使得轉接通道第二開口穿透樣本容器蓋。 It should be understood that one or more of the following features can be applied to any of the embodiments described herein. Optionally, no liquid communication is formed between the collection channel and the interior of the sample container until the body fluid reaches the second opening of the collection channel. Optionally, the device includes two collection channels, and no liquid communication is formed between the collection channels and the interior of the sample container until the second openings of the two collection channels all have body fluids arriving. Optionally, the second opening of the collection channel in the device is configured to penetrate the cover of the sample container, and wherein the relative movement between the second opening of the collection channel and the sample container is provided to form the second opening of the collection channel and the sample container The liquid flow path allows the second opening of the collection channel to penetrate the sample container lid. Optionally, the device is provided with a transition channel for each collection channel in the device, the transition channel has a first opening and a second opening, the first opening is configured to contact the second opening of the collection channel, the second opening is It is configured to penetrate the sample container lid, and by providing (a) the second opening of the collection channel, (b) the transition channel and (c) the relative movement between two or more of the sample container to form the collection channel The liquid flow path between the sample container and the second opening of the adapter channel penetrates the sample container cover.

於本文所述之另一實施例中，係提供有一種自對象採集體液樣本之方法，其包括(a)使具有第一通道及第二通道之裝置與採自對象之體液形成液體連通，各通道具有輸入開口，其被配置為與所述體液形成液體連通，各通道於各通道輸入開口下游具有輸出開口，且各通道被配置為籍由毛細作用將體液自輸入開口朝輸出開口抽吸；(b)透過各第一通道及第二通道之輸出開口，使該第一通道及第二通道與第一容器及第二容器分別形成液體連通；及(c)借助(i)該第一容器或第二容器中相對於環境壓力之負壓，其中所述負壓足以影響所述體液透過該第一通道或第二通道進入其相應容器之流動，或(ii)該第一通道或第二通道上游相對於環境壓力之正壓，其中所述正壓足以影響所述全血樣本透過該第一通道或第二通道進入其相應容器之流動，引導該第一通道及第二通道之各條中所述體液至各第一容器及第二容器。 In another embodiment described herein, there is provided a method for collecting a body fluid sample from a subject, which includes (a) forming a device having a first channel and a second channel in liquid communication with a body fluid collected from the subject, each The channel has an input opening configured to form liquid communication with the body fluid, each channel has an output opening downstream of each channel input opening, and each channel is configured to draw body fluid from the input opening toward the output opening by capillary action; (b) through the output openings of each first channel and second channel, the first channel and the second channel are in liquid communication with the first container and the second container, respectively; and (c) by (i) the first container Or a negative pressure relative to the ambient pressure in the second container, wherein the negative pressure is sufficient to affect the flow of the body fluid into its corresponding container through the first channel or the second channel, or (ii) the first channel or the second The positive pressure upstream of the channel relative to the ambient pressure, wherein the positive pressure is sufficient to affect the flow of the whole blood sample into its corresponding container through the first channel or the second channel, guiding the strips of the first channel and the second channel The body fluid described in each of the first container and the second container.

於本文所述之另一實施例中，係提供有一種製造樣本採集裝置之方法，其包括形成具有至少兩條通道的樣本採集裝置之一部分，所述兩條通道被配置為籍由第一類型動力同時將液體樣本抽吸入該至少兩條樣本採集通道中的每一條中；形成樣本容器，由此所述容器被配置為與樣本採集裝置耦合，提供與用於採集樣本之第一動力不同的第二動力，以將體液樣本從該通道移至容器中。 In another embodiment described herein, there is provided a method of manufacturing a sample collection device, which includes forming a portion of a sample collection device having at least two channels, the two channels configured to be of a first type The power simultaneously draws the liquid sample into each of the at least two sample collection channels; a sample container is formed, whereby the container is configured to couple with the sample collection device, providing a first power different from that used to collect the sample The second power to move the body fluid sample from the channel to the container.

於本文所述之另一實施例中，係提供有電腦可執行之指令，用於完成一種方法，包括：形成具有至少兩 條通道的樣本採集裝置之一部分，所述兩條通道被配置為籍由第一類型動力同時將液體樣本抽吸入該至少兩條樣本採集通道中的每一條中。 In another embodiment described herein, a computer-executable instruction is provided for performing a method, including: forming at least two A part of the sample collection device of each channel, the two channels are configured to simultaneously draw a liquid sample into each of the at least two sample collection channels by the first type of power.

於本文所述之另一實施例中，係提供有電腦可執行之指令，用於完成一種方法，包括：形成樣本容器，由此所述容器被配置為與樣本採集裝置耦合，提供與用於採集樣本之第一動力不同的第二動力，以將體液樣本從該通道移至容器中。 In another embodiment described herein, computer-executable instructions are provided for performing a method, including: forming a sample container, whereby the container is configured to be coupled with a sample collection device, provided and used for A second power different from the first power of the sample is collected to move the body fluid sample from the channel to the container.

於本文所述之又一實施例中，係提供有一種自對象採集體液樣本之裝置，包括：用於自所述裝置與對象接觸之單個端抽取體液樣本入裝置中的構件，由此將液體樣本分為兩個單獨樣本；用於傳遞液體樣本進入複數個樣本容器中的構件，其中所述容器提供動力將所述兩個單獨樣本之多數從所述路徑移入所述容器中。 In yet another embodiment described herein, there is provided a device for collecting a body fluid sample from a subject, including: a member for drawing a body fluid sample into the device from a single end of the device in contact with the subject, thereby transferring the liquid The sample is divided into two separate samples; a member for transferring a liquid sample into a plurality of sample containers, wherein the container provides power to move the majority of the two separate samples from the path into the container.

儘管以上為本文所述較佳實施例之完整說明，惟依然有可能採用各種替代、修改及等同形式。因此，本發明之範疇應由後附申請專利範圍及其全部等同方案，而不是以上說明限定。不論是否為較佳的任意特徵皆可與不論是否為較佳的其他任意特徵組合。後附申請專利範圍不得被解釋為包括手段功能之界定，除非某一請求項使用短語“手段，用於”明確引用此類界定。應瞭解，如本文用法且於全部後附申請專利範圍中，“一”和“此”的含義包括複數形式，上下文中明確另行指定者除外。另外，如本文用法且於全部後附申請專利範圍中，“中”的含義包 括“中”和“上”，上下文中明確另行指定者除外。最後，如本文用法且於全部後附申請專利範圍中，“和”及“或”的含義既有和，也有或，且可彼此交換使用，上下文中明確另行指定者除外。因此，於使用“和”及“或”的上下文中，此類連接詞的使用不排除“和/或”的含義，上下文中明確另行指定者除外。 Although the above is a complete description of the preferred embodiments described herein, it is still possible to use various alternatives, modifications, and equivalents. Therefore, the scope of the present invention should be limited by the appended patent application and all its equivalents, rather than the above description. Any feature whether it is better or not can be combined with any other feature whether it is better or not. The scope of the attached patent application shall not be interpreted as including the definition of the function of the means, unless a claim item uses the phrase "means for" to explicitly quote such definition. It should be understood that, as used herein and in the scope of all attached patent applications, the meanings of "a" and "this" include plural forms, unless the context clearly specifies otherwise. In addition, as used in this text and in the scope of all attached patent applications, the meaning of "中" includes Include "middle" and "upper" unless the context clearly specifies otherwise. Finally, as used in this document and in the scope of all attached patent applications, the meanings of "and" and "or" are both "sum" and "or", and can be used interchangeably, unless the context clearly specifies otherwise. Therefore, in the context of using "and" and "or", the use of such conjunctions does not exclude the meaning of "and / or", unless the context clearly specifies otherwise.

本文件包含受著作權保護之資料。著作權持有者(本文中的申請人)不反對傳真複製美國專利商標局專利文件或記錄中的有關專利文件及揭示，然保留一切著作權。應採用以下說明：著作權2013 Theranos,Inc.。 This document contains information protected by copyright. The copyright holder (applicant in this article) has no objection to facsimile copying of relevant patent documents and disclosures in the US Patent and Trademark Office patent documents or records, but reserves all copyrights. The following instructions should be used: Copyright 2013 Theranos, Inc ..

Claims (22)

一種運用採自對象之小體積體液樣本完成兩項或更多項實驗室測試的方法，該方法包含：將至少一第一器皿和一第二器皿自樣本採集地點運送至樣本接收地點，該第一及第二器皿各自包含採自對象之小體積體液樣本之一部分，其中該採自該對象之小體積體液樣本之總體積不大於400微升，其中該等運送包含將該第一器皿及第二器皿放置於位在一托盤內之開口以及在一溫度控制容器中運送該托盤；將該托盤從該等溫度控制容器中移出並掃描置於該托盤中之器皿上的資訊儲存單元；及於樣本接收地點分置該第一器皿中所運送之小體積體液樣本部分之至少一部分以用於一第一實驗室測試，並分置該第二器皿中所運送之小體積體液樣本部分之至少一部分以用於一第二實驗室測試。A method for completing two or more laboratory tests using a small-volume body fluid sample collected from a subject. The method includes: transporting at least a first vessel and a second vessel from a sample collection site to a sample receiving site, the first The first and second vessels each contain a portion of a small volume of bodily fluid sample collected from the subject, wherein the total volume of the small volume of bodily fluid sample collected from the subject is not greater than 400 microliters, wherein the transportation includes the first vessel and the second vessel Two vessels are placed in an opening in a tray and the tray is transported in a temperature-controlled container; the tray is removed from the temperature-controlled containers and the information storage unit on the vessel placed in the tray is scanned; and The sample receiving location divides at least a portion of the small volume body fluid sample portion transported in the first vessel for a first laboratory test, and divides at least a portion of the small volume body fluid sample portion transported in the second vessel Used for a second laboratory test. 一種運用採自對象之體液樣本完成兩項或更多項實驗室測試的方法，該方法包含：將複數個器皿自樣本採集地點運送至樣本接收地點，該複數個器皿共同含有採自對象之小體積體液樣本，其中該複數個器皿包含至少一第一器皿和一第二器皿，其中該第一及第二器皿各自含有採自該對象之小體積體液樣本之一部分，且其中該複數個器皿之所有器皿中該採自該對象之小體積體液樣本之總體積不大於400微升，其中該等運送包含將該第一器皿及第二器皿放置在一托盤中之開口中以及在一溫度控制容器中運送該托盤；將該托盤從該等溫度控制容器中移出並掃描該等容器的條碼；及於樣本接收地點分置該第一器皿中所運送之小體積體液樣本部分之至少一部分以用於一第一實驗室測試，並分置該第二器皿中所運送之小體積體液樣本部分之至少一部分以用於一第二實驗室測試。A method for completing two or more laboratory tests using a body fluid sample collected from a subject. The method includes: transporting a plurality of utensils from a sample collection location to a sample receiving location, the plurality of utensils together containing a small sample collected from the subject Volume body fluid sample, wherein the plurality of vessels includes at least a first vessel and a second vessel, wherein the first and second vessels each contain a portion of a small volume of body fluid sample taken from the subject, and wherein the plurality of vessels The total volume of the small-volume body fluid sample collected from the subject in all vessels is not more than 400 microliters, wherein the transportation includes placing the first vessel and the second vessel in an opening in a tray and a temperature-controlled container Transport the tray in the middle; remove the tray from the temperature-controlled containers and scan the barcodes of the containers; and divide at least a portion of the small-volume body fluid sample portion transported in the first vessel at the sample receiving site for use A first laboratory test, and divide at least a part of the small volume body fluid sample portion transported in the second vessel for a second laboratory test. 一種運用採自對象之小體積體液樣本完成兩項或更多項實驗室測試的方法，該方法包含：將至少一第一器皿和一第二器皿自樣本採集地點運送至樣本接收地點，該第一及第二器皿各自含有採自對象之小體積體液樣本之一部分，其中該採自該對象之小體積體液樣本之總體積不大於400微升，其中該等運送包含將該第一器皿及第二器皿放置於在在一托盤內之開口以及在一溫度控制容器中運送該托盤；將該托盤從該等溫度控制容器中移出並掃描該等容器的條碼；於樣本接收地點，將一第一器皿初始樣本從該第一器皿中移除，其中該第一器皿初始樣本為該第一器皿中所運送之小體積體液樣本部分之至少一部分；從該第一器皿初始樣本產生第一器皿稀釋樣本，其中該第一器皿稀釋樣本：i)相較於該第一器皿初始樣本，被稀釋至少3倍，及ii)具有不超過1000微升之總體積，及於樣本接收地點，分置該第一器皿中所運送之小體積體液樣本部分之至少一部分以用於一第一實驗室測試，並分置該第二器皿中所運送之小體積體液樣本部分之至少一部分以用於一第二實驗室測試。A method for completing two or more laboratory tests using a small-volume body fluid sample collected from a subject. The method includes: transporting at least a first vessel and a second vessel from a sample collection site to a sample receiving site, the first The first and second vessels each contain a portion of a small volume of bodily fluid sample collected from the subject, wherein the total volume of the small volume of bodily fluid sample collected from the subject is not more than 400 microliters, wherein the transportation includes the first vessel and the second vessel Two vessels are placed in an opening in a tray and the tray is transported in a temperature-controlled container; the tray is removed from the temperature-controlled containers and the barcodes of the containers are scanned; at the sample receiving location, a first The initial vessel sample is removed from the first vessel, where the first vessel initial sample is at least a portion of the small volume of body fluid sample portion transported in the first vessel; a first vessel dilution sample is generated from the first vessel initial sample , Where the first vessel dilutes the sample: i) is diluted at least 3 times compared to the first vessel initial sample, and ii) has a total volume of not more than 1000 μl, and the At least a portion of the small volume body fluid sample portion transported in a vessel for a first laboratory test, and divide at least a portion of the small volume body fluid sample portion transported in the second vessel for a second experiment Room testing. 一種運用採自對象之小體積體液樣本完成兩項或更多項實驗室測試的方法，該方法包含：將一器皿自樣本採集地點運送至樣本接收地點，該器皿含有採自對象之小體積體液樣本，其中該器皿中之該小體積體液樣本之體積不大於400微升，其中該等運送包含將該第一器皿及第二器皿放置在一托盤中之開口中以及在一溫度控制容器中運送該托盤；將該托盤從該等溫度控制容器中移出並掃描該等容器的條碼；及於樣本接收地點，分置該第一器皿中所運送之小體積體液樣本部分之至少一部分以用於一第一實驗室測試，並分置該第二器皿中所運送之小體積體液樣本部分之至少一部分以用於一第二實驗室測試。A method for completing two or more laboratory tests by using a small volume of body fluid sample collected from a subject Samples, wherein the volume of the small volume body fluid sample in the vessel is not greater than 400 microliters, wherein the transporting includes placing the first and second vessels in an opening in a tray and transporting in a temperature-controlled container The tray; remove the tray from the temperature control containers and scan the barcodes of the containers; and at the sample receiving location, divide at least a portion of the small volume body fluid sample portion transported in the first vessel for use in a The first laboratory test, and divide at least a part of the small volume body fluid sample portion transported in the second vessel for a second laboratory test. 一種運用採自對象之小體積體液樣本完成兩項或更多項實驗室測試的方法，該方法包含：將一器皿自樣本採集地點運送至樣本接收地點，該器皿含有採自對象之小體積體液樣本，其中該器皿中之小體積體液樣本之體積不大於400微升，其中該等運送包含將該第一器皿及第二器皿放置於位在一托盤內之開口以及在一溫度控制容器中運送該托盤；將該托盤從該等溫度控制容器中移出並掃描該等容器的條碼；於樣本接收地點，將一初始樣本從該器皿中移除，其中該初始樣本為該器皿中之小體積體液樣本的至少一部分；從該初始樣本產生至少一第一稀釋樣本及一第二稀釋樣本，其中該第一稀釋樣本：i)相較於該初始樣本，被稀釋至少2倍，及ii)具有不超過1000微升之總體積，以及其中該第二稀釋樣本：i)相較於該初始樣本，被稀釋至少5倍，及ii)具有不超過1000微升之總體積，及於樣本接收地點，分置該第一器皿中所運送之小體積體液樣本部分之至少一部分以用於一第一實驗室測試，並分置該第二器皿中所運送之小體積體液樣本部分之至少一部分以用於一第二實驗室測試。A method for performing two or more laboratory tests using a small volume of body fluid sample collected from a subject, the method comprising: transporting a vessel from a sample collection site to a sample receiving site, the vessel containing a small volume of body fluid collected from the subject Sample, wherein the volume of the small volume body fluid sample in the vessel is not more than 400 microliters, wherein the transportation includes placing the first vessel and the second vessel in an opening in a tray and transporting in a temperature-controlled container The tray; remove the tray from the temperature control containers and scan the barcodes of the containers; at the sample receiving site, remove an initial sample from the vessel, wherein the initial sample is a small volume of body fluid in the vessel At least a portion of the sample; at least a first diluted sample and a second diluted sample are generated from the initial sample, wherein the first diluted sample: i) is at least 2 times diluted compared to the initial sample, and ii) has no A total volume exceeding 1000 μl, and wherein the second diluted sample: i) is diluted at least 5 times compared to the initial sample, and ii) has a total volume not exceeding 1000 μl, and at the sample receiving site, Divide at least a portion of the small volume body fluid sample portion transported in the first vessel for a first laboratory test, and divide at least a portion of the small volume body fluid sample portion transported in the second vessel for A second laboratory test. 如請求項1-5中任一項之方法，其中該第一器皿及該第二器皿的內部體積各為300微升或更少。The method of any one of claims 1-5, wherein the internal volume of the first vessel and the second vessel are each 300 microliters or less. 如請求項1-5中任一項之方法，其中該第一器皿及該第二器皿所含有之小體積體液樣本部分之體積皆不大於250微升。The method according to any one of claims 1 to 5, wherein the volume of the small-volume body fluid sample portion contained in the first vessel and the second vessel is not more than 250 microliters. 如請求項1-5中任一項之方法，其中至少該第一器皿含有填充至少80%的該器皿內部體積之體液樣本。The method of any one of claims 1-5, wherein at least the first vessel contains a body fluid sample that fills at least 80% of the internal volume of the vessel. 如請求項1-5中任一項之方法，其中該樣本採集地點與該樣本接收地點處於不同建築物中。The method according to any one of claims 1-5, wherein the sample collection location and the sample reception location are in different buildings. 如請求項1-5中任一項之方法，其中於自樣本採集地點運送該第一器皿至樣本接收地點過程中，至少該第一器皿中的小體積體液樣本部分被保持於液體形態。The method of any one of claims 1-5, wherein during the transportation of the first vessel from the sample collection site to the sample receiving site, at least a portion of the small volume body fluid sample in the first vessel is maintained in a liquid form. 如請求項1-5中任一項之方法，其中該第一器皿及該第二器皿係於一運送容器中被自樣本採集地點運送至樣本接收地點，其中該第一及第二器皿以陣列形式定位於該運送容器中，且其中當從上往下觀察時，該陣列每平方英寸包含至少四個樣本器皿。The method of any one of claims 1-5, wherein the first vessel and the second vessel are transported from a sample collection site to a sample reception site in a shipping container, wherein the first and second vessels are arrayed The format is positioned in the shipping container, and wherein when viewed from above, the array contains at least four sample vessels per square inch. 如請求項1-5中任一項之方法，其中該運送容器含有採自至少3個不同對象之體液樣本。The method of any one of claims 1-5, wherein the shipping container contains body fluid samples taken from at least 3 different subjects. 如請求項1-5中任一項之方法，其中至少該第一器皿包含一抗凝劑。The method of any one of claims 1-5, wherein at least the first vessel contains an anticoagulant. 如請求項1-5中任一項之方法，其中該第一器皿及該第二器皿各包含一抗凝劑。The method of any one of claims 1-5, wherein the first vessel and the second vessel each include an anticoagulant. 如請求項1-5中任一項之方法，其中該第一器皿及該第二器皿各包含一抗凝劑，且其中該第一器皿中的抗凝劑不同於該第二器皿中的抗凝劑。The method of any one of claims 1-5, wherein the first vessel and the second vessel each include an anticoagulant, and wherein the anticoagulant in the first vessel is different from the anticoagulant in the second vessel Coagulant. 如請求項1-5中任一項之方法，其中該體液樣本於其從該對象獲取後不超過24小時抵達該樣本接收地點。The method of any of claims 1-5, wherein the body fluid sample arrives at the sample receiving location no more than 24 hours after it is obtained from the subject. 如請求項1-5中任一項之方法，其中該體液樣本為全血。The method of any one of claims 1-5, wherein the body fluid sample is whole blood. 如請求項1-5中任一項之方法，其中該體液樣本為血漿或血清。The method of any one of claims 1-5, wherein the body fluid sample is plasma or serum. 如請求項1-5中任一項之方法，其中至少該第一器皿包含一分隔凝膠，其中該凝膠促進全血分離為血漿或血清及細胞層，器皿中該凝膠沈澱於該血漿或血清層與細胞層之間的一層中。The method of any one of claims 1-5, wherein at least the first vessel comprises a separation gel, wherein the gel promotes separation of whole blood into plasma or serum and a cell layer, and the gel in the vessel is precipitated on the plasma Or in a layer between the serum layer and the cell layer. 如請求項1-5中任一項之方法，其進一步包含於自該樣本採集地點將一包含小體積體液樣本之至少一部分的第一器皿運送至該樣本接收地點前，離心分離至少該第一器皿。The method of any of claims 1-5, further comprising centrifuging at least the first vessel before transporting a first vessel containing at least a portion of a small volume of body fluid sample from the sample collection site to the sample receiving site Utensils. 如請求項1-5中任一項之方法，其進一步包含於該樣本接收地點且於從該第一器皿中移除樣本前，將該第一器皿***包含自動液體處置儀器之樣本處理裝置中。The method of any one of claims 1-5, further comprising at the sample receiving location and before removing the sample from the first vessel, inserting the first vessel into a sample processing device including an automatic liquid disposal instrument . 如請求項1-5中任一項之方法，其中該第一器皿初始樣本為血漿、血清、全血、尿樣、唾液或鼻咽棉花拭子或抽吸物。The method of any one of claims 1-5, wherein the initial sample of the first vessel is plasma, serum, whole blood, urine sample, saliva, or nasopharyngeal cotton swab or aspirate.